[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Australian and New Zealand Intensive Care Research Centre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":433},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,56,86,116,144,171,207,244,266,288,311,333,354,383,410],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100556548","phase-3-recommend-platform-trial-100556548",false,"NCT06526533","RECOMMEND Platform Trial","Generating New Evidence to Reduce Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)","RECOMMEND","PLATFORM INCLUSION CRITERIA:\n\n* Patients receiving ECMO\n* Patients enrolled in the EXCEL Registry - NCT03793257\n\nPLATFORM EXCLUSION CRITERIA:\n\n* Treating clinician regards death as imminent and inevitable\n* Treating clinician determines it is not in the patient's best interests\n\nRBC TRANSFUSION DOMAIN INCLUSION CRITERIA:\n\n• Aged 18 years or older\n\nRBC TRANSFUSION DOMAIN EXCLUSION CRITERIA:\n\n* Contraindication to RBC transfusion (including known patient preference)\n* Limitations of care put in place either through patient wishes or the treating medical teams.\n* Participant has already received ECMO \\>12 hours. The start of ECMO is defined as the time of initiation of extracorporeal blood flow unless ECMO was initiated during a surgical intervention in which case the start of ECMO is defined as the arrival time into the initial ICU (post-surgery)\n* The treating physician anticipates that ECMO treatment will cease before the end of tomorrow\n* The treating physician deems the study is not in the patient's best interest\n* The treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds\n* Actively listed for a solid organ transplant and has not yet received one\n* Suspected or confirmed to be pregnant\n* Previous ECMO treatment during the same hospital admission",true,"ALL",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO)\n\nThe main question the platform trial aims to address is to determine the effect of a range of interventions on survival, organ support and resource utilisation to day 28 for hospitalised patients receiving ECMO.\n\nResearchers will compare various interventions within multiple platform trial domains to see if the interventions have effects on survival, organ support and resource utilisation for the patient cohort.\n\nParticipants will be enrolled in accordance with the platform trial's domain structure to answer the research questions.",[27,28,29,30,31],"Extracorporeal Membrane Oxygenation Complication","ARDS (Acute Respiratory Distress Syndrome)","Intensive Care Medicine","Cardiac Arrest (CA)","Critical Illness",[33,34,35,36,37,38,39,40,41,42],"ECMO","ICU","Platform Trial","Australia","Cardiac","Respiratory","VA","VV","eCPR","Adaptive","RECRUITING","2026-05-11",{"date":46,"type":47},"2026-05-13","ACTUAL",{"date":49,"type":47},"2026-03-23",{"date":51,"type":21},"2029-06",{"name":53,"class":54},"Australian and New Zealand Intensive Care Research Centre","OTHER",3,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":18,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100409218","phase-2-bone-loss-prevention-with-zoledronic-acid-or-denosumab-in-critically-ill-adults-100409218","NCT04608630","Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults","Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial","BoneZone","Inclusion Criteria:\n\n* Female age ≥ 50 years or male age ≥ 70 years\n* Has been in the Intensive Care Unit for 2 or more calendar days and is not expected to be discharged from the Intensive Care Unit on the second day\n* Has required Intensive Care Unit level support (i.e. intravenous vasoactive drugs, or invasive mechanical ventilation, or non-invasive ventilation or high flow nasal oxygen at Fraction inspired Oxygen ≥0.4 and\u002For gas flows ≥40L\u002Fm) for a minimum cumulative duration of 6 hours\n* Expected to survive the current hospital admission\n\nExclusion Criteria:\n\n* Cancer related metastatic bone disease or multiple myeloma\n* Paget's disease\n* Pregnancy\n* Current estimated Glomerular Filtration Rate \\\u003C30ml\u002Fmin or receiving renal replacement therapy\n* Known contraindication to denosumab or zoledronic acid\n* Obvious holes in teeth or broken teeth or dental or gum infection\n* Known untreated hypoparathyroidism\n* Current treatment with anti-fracture agent (bisphosphonate, strontium or teriparatide within previous 2 years, or menopausal hormone therapy or romosozumab within previous 12-months or denosumab within previous 6 months)\n* Current fragility fracture of hip, spine, femur or forearm\n* Exceeds weight limit for BMD scan at site or unable to undertake Bone Mineral Density for any reason\n* International Normalised Ratio \\> 3.0 or Platelet count \\\u003C 30 10\\^9\u002FL","50 Years",{"count":66,"type":21},450,[68],"PHASE2","The Bone Zone trial is a prospective, multi-centre, double-blind, phase II, randomised controlled trial evaluating the effect of denosumab or zoledronic acid compared to placebo on change in bone mineral density over one year in women aged 50 years or older and men aged 70 years or older requiring admission to intensive care for greater than 24 hours.\n\n450 women aged 50 years or older and men aged 70 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.",[31,71],"Osteoporosis",[73,71,74,75,76],"Intensive Care Unit","Bone densitometry","Zoledronic acid","Denosumab","2026-03-02",{"date":79,"type":47},"2026-03-04",{"date":81,"type":47},"2021-07-15",{"date":83,"type":21},"2027-02-28",{"name":53,"class":54},22,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100626640","phase-2-the-aminoecmo-pilot-trial-100626640","NCT07438262","The AminoECMO Pilot Trial","A Pilot, Three-centre, Placebo Controlled, Physiology and Feasibility Randomised Controlled Trial of Intravenous Amino Acid Therapy in ECMO Dependent Adults Admitted to the Intensive Care Unit","AminoECMO","Inclusion Criteria:\n\n* Aged ≥18 years\n* Enrolled in the EXCEL Registry\n\nExclusion Criteria:\n\n* Urea level ≥30 mmol\u002FL\n* Requirement for renal replacement therapy\n* Chronic hemodialysis or peritoneal dialysis\n* ECMO for ≥24 hours\n* Pre-admission CKD with an eGFR \\\u003C30 ml\u002Fmin\n* Previous enrolment in this study\n* Pregnant or Lactating\n* Known contraindication to AA infusion\n* ECMO expected to cease ≤24 hours\n* Expected to be transferred to another hospital ≤24 hours\n* Treating clinical team deems study is not in the patient's best interest","18 Years","65 Years",{"count":97,"type":21},40,[68],"Acute kidney injury (AKI) is a serious problem for patients in intensive care, especially those on life-support machines like ECMO (which helps the heart and lungs). More than half of these patients develop severe kidney problems that often require dialysis, and this greatly increases the risk of poor outcomes.\n\nDoctors try to prevent AKI by treating the underlying illness, avoiding kidney-harming drugs, and carefully managing fluids. But these methods are mostly supportive - they don't actively improve kidney function.\n\nStudies in surgical patients (especially heart and urology operations) show that giving amino acids before surgery can reduce the chance of developing AKI. A major clinical trial even found that this approach significantly lowered AKI rates in heart surgery patients.\n\nAmino acids (the building blocks of protein) seem to boost kidney performance. When given through a drip or feeding tube, they increase blood flow to the kidneys and may \"wake up\" unused kidney capacity - a concept called \"functional renal reserve.\" It's not yet clear whether amino acids help critically ill patients on ECMO. More research is needed to see if this promising strategy can improve kidney function and outcomes in the sickest patients.",[101],"Acute Kidney Injury",[103,104,105],"Acute kidney injury","Extracorporeal Membrane Oxygenation","Amino Acids","NOT_YET_RECRUITING","2026-02-22",{"date":109,"type":47},"2026-02-27",{"date":111,"type":21},"2026-02-01",{"date":113,"type":21},"2027-11-30",{"name":53,"class":54},1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100473818","phase-3-fibrinogen-early-in-severe-trauma-study-ii-100473818","NCT05449834","Fibrinogen Early In Severe Trauma StudY II","FEISTY II","Inclusion Criteria:\n\n1. Adult affected by trauma (≥18yrs)\n2. Judged to have active haemorrhage by treating clinician\n3. Activation of local MHP and\u002For Transfusion of Emergency Blood Products\n4. FIBTEM A5 ≤ 10mm or TEG FF A5 ≤ 15mm or FibC ≤ 2 g\u002Fl\n\nExclusion Criteria:\n\n1. Injury judged incompatible with survival\n2. Randomisation unable to occur within 6 hours of presentation to hospital\n3. Known pregnancy\n4. Known genetic or drug induced coagulation disorder\n5. Known objection to blood products\n6. Dedicated prior fibrinogen replacement\n7. Participation in a competing study","100 Years",{"count":125,"type":21},900,[24],"Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.\n\nCurrently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.\n\nFibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.\n\nThe timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.\n\nFEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate",[129,130,131],"Trauma","Haemorrhagic Shock","Coagulopathy",[133,134],"Fibrinogen","Cryoprecipitate","2026-02-03",{"date":137,"type":47},"2026-02-05",{"date":139,"type":47},"2022-11-21",{"date":141,"type":21},"2026-12-01",{"name":53,"class":54},24,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":18,"minAge":95,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100606469","phase-3-improving-survivorship-for-critically-ill-patients-aged-65-and-over-100606469","NCT07175961","Improving Survivorship for Critically Ill Patients Aged 65 and Over","IMPROVE-65","Inclusion Criteria:\n\n* Was admitted to ICU for at least 48 hours\n* is aged 65 years or older at the time of hospital admission\n* Is alive and ready for hospital discharge\n* Is expected to survive for 6 months beyond hospital discharge (e.g. not discharged on palliative care)\n* Has new disability at hospital discharge measured using the global disability scale\n\nExclusion Criteria:\n\n* Is not expected to reside in Australia for 3 months following randomisation.\n* Is not expected to be living at home within 2 weeks of acute hospital discharge (e.g. prolonged inpatient rehabilitation)\n* Is unable to identify a GP or GP clinic and\u002For are unable or unwilling to attend a GP appointment scheduled by the recovery navigator.\n* Has an existing recovery or nurse navigator as part of their routine clinical care to assist with planning their care after hospital discharge",{"count":152,"type":21},300,[24],"IMPROVE-65 is a randomised control trial designed specifically for people aged over 65 who have survived critical illness. It aims to support patients and general practitioners by providing timely, personalised information to help them work together to make informed goals and decisions about their care after hospital discharge. The aim of the study is to improve recovery and avoid preventable hospital readmissions.",[31,156,157],"Recovery Outcomes","Care Coordination",[159,160,161],"critical illness","recovery coordination","patient reported outcomes","2025-09-16",{"date":164,"type":47},"2025-09-19",{"date":166,"type":21},"2025-11",{"date":168,"type":21},"2028-02",{"name":53,"class":54},2,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":192,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100407660","phase-3-erythropoietin-alfa-to-prevent-mortality-and-reduce-severe-disability-in-critically-ill-trauma-patients-100407660","NCT04588311","ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients","A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury","EPO-TRAUMA","Inclusion Criteria: Patients with trauma admitted to the ICU who:\n\n* Are ≥ 18 to ≤ 75 years of age\n* Are \\\u003C 24 hours since primary traumatic injury\n* Are invasively mechanically ventilated\n* Are expected to stay in the ICU ≥ 48 hours\n* Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution\n* Have informed consent from a legal surrogate according to local law\n\nExclusion Criteria: Patients will be excluded from the study if any of the following criteria apply:\n\n* GCS = 3 and fixed dilated pupils\n* Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)\n* A chronic hypercoagulable disorder, including known malignancy\n* Treatment with EPO in the last 30 days\n* First dose of study drug unable to be given within 24 hours of primary injury\n* Pregnancy or lactation or 3 months postpartum\n* Expected to die imminently (\\\u003C 24 hours)\n* Known sensitivity to mammalian cell derived products\n* Known contraindication to epoetin alfa\n* End stage renal failure (receives chronic dialysis)\n* Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome\n* The treating physician believes it is not in the best interest of the patient to be randomised to this trial","75 Years",{"count":181,"type":21},2500,[24],"The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients.\n\n2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.",[129,185,186,187,188,189,190,191],"Traumatic Injury","Traumatic Brain Injury","Wounds and Injuries","Penetrating Injury","Blunt Injury","Major Trauma","Multiple Trauma",[73,129,193,194,195,196,197],"Major trauma","Traumatic injury","EPO","Erythropoietin","Epoetin alfa","2025-07-14",{"date":200,"type":47},"2025-07-16",{"date":202,"type":47},"2020-11-09",{"date":204,"type":21},"2027-08-31",{"name":53,"class":54},41,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":17,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":170},"100501810","red-blood-cell-transfusion-in-ecmo---a-feasibility-trial-100501810","NCT05814094","Red Blood Cell Transfusion in ECMO - A Feasibility Trial","ROSETTA","Inclusion Criteria:\n\n* Patients receiving ECMO\n* Age: 18 years or older\n\nExclusion Criteria:\n\n* Contraindication to RBC transfusion (including known patient preference)\n* Limitations of care put in place either through patient wishes or the treating medical teams\n* ECMO treatment for more than 12 hours. The start of ECMO is defined as the time of initiation of extracorporeal blood flow unless ECMO was initiated during a surgical intervention in which case the start is defined as the arrival time into the initial ICU.\n* The treating physician anticipates that ECMO treatment will cease before the end of tomorrow\n* Where the treating physician deems the study is not in the patient's best interest\n* Where the treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds\n* Patients actively listed for a solid organ transplant\n* Patients who are suspected or confirmed to be pregnant\n* Previous ECMO treatment during the same hospital admission",{"count":215,"type":21},120,[217],"NA","Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intense treatment used to support critically ill patients who have suffered severe cardiac arrest, cardiac failure or respiratory failure (including severe cases of COVID-19). ECMO acts as a mechanical circulatory support temporarily replacing the function of the heart or lungs by oxygenating blood and removing carbon dioxide, allowing time for these organs to recover. Many critically ill patients, including those on ECMO, have an increased risk of bleeding and reduced production\u002Fincreased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels \\\u003C120 g\u002Fl), a condition where the body lacks enough healthy RBCs to carry enough oxygen to the body's tissues. Therefore, patients on ECMO frequently require RBC transfusion, with clinicians having to decide if administering an RBC transfusion (with its associated risks) is higher than tolerating complications of anaemia.\n\nROSETTA is a feasibility study that aims to determine the safety and feasibility of randomizing patients on ECMO to a restrictive RBC transfusion strategy (maintain Hb concentration above 70g\u002FL) or to a more liberal transfusion strategy (maintain Hb concentration above 90g\u002FL). Feasibility is defined as the ability to achieve a mean separation of at least 10g\u002FL between the average lowest daily haemoglobin values in the two study groups.",[220,27,221,222,223],"Blood Loss Anemia","Disability Physical","Cognitive Ability, General","Functional Status",[225,226,33,227,228,229,36,230,34,231,232,233,234,235],"Hb","RBC transfusion","feasibility","safety","blood transfusion","blood products","critical care","intensive care","bleeding","transfusion","Hb values","2025-05-27",{"date":238,"type":47},"2025-05-31",{"date":240,"type":47},"2023-09-20",{"date":242,"type":21},"2025-12-30",{"name":53,"class":54},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100474105","restricted-or-liberal-fluid-for-haemodynamic-resuscitation-in-sepsis-100474105","NCT05453565","Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis","Fluid Restricted Resuscitation in Sepsis With Hypotension Meta-Analysis (FRESHLY): Individual Patient Data Met-analysis of the ARISE FLUIDS, CLASSIC, CLOVERS and EVIS Trials","FRESHLY","Inclusion Criteria:\n\nParticipants of the ARISE FLUIDS, CLASSIC, CLOVERS \\& EVIS trials who had:\n\n* Suspected or proven infection\n* Systolic blood pressure (SBP) \\\u003C100 mm Hg OR mean arterial pressure (MAP) \\\u003C65 mm Hg\n* Lactate ≥ 2.0 mmol\u002FL\n* Requirement for vasopressors to meet perfusion targets\n\nExclusion criteria:\n\nParticipants not in the ARISE FLUIDS, CLASSIC, CLOVERS \\& EVIS trials",{"count":253,"type":21},7838,"OBSERVATIONAL","A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.",[257,258],"Septic Shock","Fluid Resuscitation","2025-01-01",{"date":261,"type":47},"2025-01-03",{"date":166,"type":21},{"date":264,"type":21},"2026-11",{"name":53,"class":54},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":115},"100560419","nutrition-practice-in-critically-ill-adults-100560419","NCT06576895","Nutrition Practice in Critically Ill Adults","Nutrition Practice in Critically Ill Adults - an Observational Study","NUTRIENT","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Admitted to ICU after 00:00 on the date of study commencement\n3. Remain in ICU for ≥ 48 hours\n\nExclusion Criteria:\n\n1. Patients who have been deemed ready to be discharged by the treating team within 48 hours of ICU admission but have not been able to be discharged within 48 hours of ICU admission for logistical reasons (e.g., due to bed unavailability, inability to return home)\n2. Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission",{"count":20,"type":21},"To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing.\n\nThe aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.",[31],[278,279],"Intensive Care","Nutrition","2024-11-27",{"date":282,"type":47},"2024-12-02",{"date":284,"type":47},"2024-08-26",{"date":286,"type":21},"2027-12-31",{"name":53,"class":54},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":18,"minAge":296,"maxAge":94,"enrollmentInfo":297,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":310},"100569502","nutrition-in-paediatric-critical-care-100569502","NCT06695078","Nutrition in Paediatric Critical Care","Nutrition in Paediatric Critical Care: a Bi-national Prospective Cohort Study","ePICUre","Inclusion Criteria:\n\n1. All patients \\\u003C\u002F=18 years of age\n2. Admitted to the PICU after 00:00 on the day of the study period commencement\n3. Admitted to the PICU for \\>72 hours\n\nExclusion Criteria:\n\n1. Those previously enrolled during the study period (i.e. those re-admitted to PICU)\n2. Those for end of life care only\n3. Those admitted for organ donation","0 Years",{"count":298,"type":21},200,"This is a multi-centre prospective cohort study of nutrition in paediatric critical care in Australia and New Zealand. The study is planned to run in parallel with the adult ICU cohort study, NUTRIENT. Two study periods are proposed with the first in late 2024 and the second in 2026. This observational study seeks to determine the following (although not limited to) descriptive outcomes of interest:\n\n1. Nutritional outcomes, including route of nutrition support (oral, enteral and\u002For parenteral), energy and protein prescription and provision, and anthropometric measures\n2. Patient-centred outcomes, including duration of invasive respiratory support and hospitalisation, and mortality\n3. Nutrition service delivery in the PICU and ward settings",[34,279,301],"Paediatric","2024-11-17",{"date":304,"type":47},"2024-11-19",{"date":306,"type":47},"2021-06-07",{"date":308,"type":21},"2027-12",{"name":53,"class":54},11,{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100504970","precision-tbi---an-observational-study-of-patients-with-moderate-to-severe-traumatic-brain-injury-100504970","NCT05855252","PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury","PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical diagnosis of moderate to severe TBI\n* Insertion of invasive intra-cranial monitoring\n* Study inclusion within 48 hours of ICU admission\n\nExclusion Criteria:\n\n* Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation\n* Advanced care directive or previously stated wish not to be included in research activities",{"count":152,"type":21},"Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.",[321],"Trauma, Brain",[323],"traumatic brain injury","2024-08-08",{"date":326,"type":47},"2024-08-12",{"date":328,"type":47},"2022-08-14",{"date":330,"type":21},"2025-07-01",{"name":53,"class":54},9,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":115},"100247363","short-period-incidence-study-of-severe-acute-respiratory-illness-100247363","NCT02498587","Short Period Incidence Study of Severe Acute Respiratory Illness","SPRINT-SARI","Inclusion Criteria:\n\n* A history of feverishness or measured fever of ≥ 38 deg C;\n* Cough;\n* Dyspnoea (shortness of breath) OR Tachypnoea.\n\nExclusion Criteria:\n\n• No exclusion criteria",{"count":341,"type":21},15000,"This is a multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with SARI. The study period will occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5 to 7-day cohort study in which patients meeting a SARI case-definition, who are newly admitted to the hospitals \u002F ICUs at participating sites, will be included in the study. The study will be conducted in 20 to 40-hospital\u002F ICU-based research networks globally. All clinical information and sample data will only be recorded if taken as part of the routine clinical practice at each site and only fully anonymised and de-identified data will be submitted centrally.\n\nThe primary aim of this study is to establishing a research response capability for a future epidemic \u002F pandemic through a global SARI observational study. The secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.",[344],"Severe Acute Respiratory Infection",[344],"2024-08-07",{"date":348,"type":47},"2024-08-09",{"date":350,"type":47},"2016-01",{"date":352,"type":21},"2026-12",{"name":53,"class":54},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":95,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":372,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100482474","trial-of-venovenous-ecmo-to-de-sedate-extubate-and-mobilise-in-hypoxic-respiratory-failure-100482474","NCT05562505","Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure","A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure","REDEEM","Inclusion Criteria:\n\n1. Patients ≥18 to 65 years old\n2. Acute hypoxemic respiratory failure characterised by new or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support\n3. Mechanical ventilation of \\\u003C7 days\n4. Moderate to severe respiratory failure, as demonstrated by two P:F ratios \\\u003C150mmHg at least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio \\> 150mmHg are permitted between the two trial inclusion ABGs.\n5. Trial of proning (unless contraindicated)\n\nExclusion Criteria:\n\n1. The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)\n2. Cardiogenic cause of respiratory failure\n3. Chronic hypercapnic respiratory failure defined as PaCO2 \\> 60 mmHg in the outpatient setting\n4. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP\u002FBIPAP used solely for sleep disordered breathing\n5. Confirmed diffuse alveolar haemorrhage from vasculitis\n6. Neurologic conditions, i.e. undergoing treatment for intracranial hypertension\n7. Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)\n8. Patient needing immediate VV ECMO (as per EOLIA criteria)\n9. The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)\n10. The patient is being transitioned to palliative care\n11. Contraindications to anticoagulation (e.g., active GI bleeding, bleeding predisposition, severe trauma)\n12. Previous hypersensitivity\u002Fanaphylactic reaction to heparin or heparin-induced thrombocytopenia\n13. Participation or Consent is declined, OR\n14. Unable to identify or Contact surrogate decision maker.",{"count":363,"type":21},140,[217],"To determine whether a strategy of adding venovenous ECMO to mechanical ventilation, as compared to mechanical ventilation alone, increases the number of intensive care free days at day 60, in patients with moderate to severe acute hypoxic respiratory failure.",[367,368,369,370,371,104],"Mechanical Ventilation Complication","Hypoxemia","Acute Respiratory Distress Syndrome Due to COVID-19","COVID-19 Respiratory Infection","Pneumonia",[73,33,104,373,374],"Mechanical Ventilation","Early ECMO","2024-08-06",{"date":348,"type":47},{"date":378,"type":47},"2022-11-28",{"date":380,"type":21},"2027-01-31",{"name":53,"class":54},7,{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":390,"targetDuration":392,"studyType":254,"phases":4,"briefSummary":393,"conditions":394,"keywords":399,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":409},"100346632","the-excel-registry-of-patients-requiring-ecmo-100346632","NCT03793257","The EXCEL Registry of Patients Requiring ECMO","The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO","Inclusion Criteria:\n\n* Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand\n\nNil Exclusion Criteria",{"count":391,"type":21},3000,"12 Months","ECMO is associated with significant costs, risks and requires specialist training and expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients requiring ECMO in Australia and New Zealand. The registry provides information on patient selection, complications, costs and patient reported outcome measures. EXCEL uses the Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and enablers to tailor implementation of evidence",[395,396,397,398],"Critically Ill","Acute Respiratory Failure","Acute Heart Failure","Cardiac Arrest",[278,400,104,401],"Critical Care","Extracorporeal Life Support","2023-09-13",{"date":404,"type":47},"2023-09-15",{"date":406,"type":47},"2019-02-01",{"date":286,"type":21},{"name":53,"class":54},29,{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100496793","precision-ecmo-in-cardiogenic-shock-evaluation-100496793","NCT05748860","PRecision Ecmo in CardIogenic Shock Evaluation","PRECISE","Inclusion Criteria:\n\n* Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)\n* 18 years old or older\n* Patients who will be enrolled in the EXCEL Registry (HREC Project 534\u002F18)\n\nExclusion Criteria:\n\n* Patients who are already on ECMO, or where\n* There are inadequate resources to complete the study",{"count":418,"type":21},236,"Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.\n\nThe PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.",[421],"Cardiogenic Shock",[33,423,424,159,232],"cardiogenic shock","ECPR","2023-02-19",{"date":427,"type":47},"2023-03-01",{"date":429,"type":21},"2023-04-03",{"date":431,"type":21},"2026-12-31",{"name":53,"class":54},""]