[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypovolemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypovolemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,80,101,126,155,177,203,231,268],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100641162","validation-of-a-wearable-bioimpedance-sensor-for-hydration-monitoring-100641162",false,"NCT07655401","Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring","Validation of a Wearable Bioimpedance Sensor for Non-Invasive Monitoring of Hydration Status","VAMOS","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Planned fluid management due to presumed dehydration\n* Expected duration of hospital stay ≥ 3 days\n\nExclusion Criteria:\n\n* Known allergies or skin sensitivities to electrode hydrogel and\u002For acrylic adhesives\n* Implantable pulse generators such as pacemakers and defibrillators, and\u002For use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.\n* Scheduled MRI\n* Scheduled diathermy\n* Breached skin at device application areas (upper back, anterior thigh and upper arm)\n* Unconsciousness\n* Critically ill (presence of acute organ dysfunction requiring intensive monitoring and management)\n* Any medical or psychiatric condition, which in the opinion of the investigator precludes participation\n* Incapable of giving informed consent","ALL","65 Years",{"count":20,"type":21},60,"ESTIMATED","OBSERVATIONAL","The purpose of the project is to validate the performance of a wearable bioimpedance sensor (Re:Balans®) for monitoring hydration status. The study includes hospitalized patients aged 65 years or older who are admitted to the hospital with suspected dehydration. Data will be collected continuously throughout the hospital stay using one sensor placed on the back, one on the upper arm, and one on the front of the thigh. Sensor measurements will be compared with multiple reference methods for assessing hydration status, including blood tests, body weight and fluid balance charts. Agreement with these reference measures will form the basis for the performance evaluation.\n\nThe anticipated benefit of the project is the validation of a novel, user-friendly, and non-invasive tool for hydration monitoring, with the aim of improving patient care, preventing complications, and reducing the need for hospital readmissions.",[25,26],"Dehydration","Hypovolemia","NOT_YET_RECRUITING","2026-06-15",{"date":30,"type":31},"2026-06-17","ACTUAL",{"date":33,"type":21},"2026-08",{"date":35,"type":21},"2027-03-31",{"name":37,"class":38},"Mode Sensors AS","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":58,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":39},"100630810","renal-and-hepatic-abnormal-doppler-patterns-in-trauma-100630810","NCT07492511","Renal and Hepatic Abnormal Doppler Patterns in Trauma","Renal and hEpatiC abnoRmal dopplEr pAtterns iN Trauma: a Multicentre Prospective Observational Study","RECREANT","Inclusion Criteria:\n\n* Age 18-65 years;\n* Admission within 24h from traumatic injury;\n* ISS \\>15\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>65;\n2. Known heart failure (NYHA ≥II);\n3. Chronic kidney disease (any stage) or chronic RRT;\n4. Chronic respiratory disease needing home O₂ or ventilation;\n5. Radiological evidence of vascular or parenchymal renal injury on trauma CT precluding reliable Doppler assessment","18 Years",{"count":50,"type":21},350,"The goal of this observational study is to learn about renal and hepatic blood flow abnormalities detected by bedside ultrasound in adult patients admitted to the intensive care unit (ICU) following major trauma.\n\nThe main questions it aims to answer are:\n\n* How reliably can trained operators measure renal Doppler and venous congestion scores (RDRI and VExUS) across different hospitals?\n* How common are abnormal kidney and liver blood flow patterns in major trauma patients during the first 72 hours of ICU admission?\n* Are these abnormal patterns associated with acute kidney injury or the need for mechanical ventilation?\n\nParticipants admitted to ICUs or high-dependency units (HDUs) with major trauma (Injury Severity Score \\>15) will undergo non-invasive bedside ultrasound assessments at admission and at 24, 48, and 72 hours. No additional treatments or interventions will be given as part of this study. Kidney function will also be checked at 6 months after hospital discharge.",[53,54,55,26,56,57],"Trauma (Including Fractures)","Trauma Patients","Kidney Disease","Hypervolemia","Kidney Failure",[59,60,61,62,63,64,65,66,67,68],"VEXUS","trauma","kidney injury","kidney failure","Venous congestion","renal perfusion","Renal Doppler resistive index","major trauma","Hemodynamic phenotyping","ICU","RECRUITING","2026-03-19",{"date":72,"type":31},"2026-03-25",{"date":74,"type":31},"2026-03-01",{"date":76,"type":21},"2030-06-30",{"name":78,"class":79},"Azienda Usl di Bologna","OTHER_GOV",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":39},"100626460","evaluate-recombinant-human-serum-albumin-from-oryza-sativa-in-patients-with-hypoalbuminemia-andor-hypovolemia-requiring-urgent-treatment-100626460","NCT07435922","Evaluate Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and\u002For Hypovolemia Requiring Urgent Treatment","Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and\u002For Hypovolemia Requiring Urgent Treatment: A ReaL World Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Hypoalbuminemia and\u002For hypovolemia requiring urgent treatment.\n* Agree to participate in this study and sign a written informed consent form by the subject themselves or their legal representative (guardian).\n* In real-world clinical practice, the attending physician has decided and planned to administer at least one dose of human albumin injection.\n\nExclusion Criteria:\n\n* Known allergy to the active ingredients or any excipients of this product.\n* Any medical condition that, in the investigator's judgment, may significantly increase the subject's risk or interfere with their participation in and completion of this study.\n* Participation in any other clinical trial of a drug at the time of enrollment in this study.",{"count":88,"type":21},2000,"This study is a post-marketing, multicenter, prospective, open-label observational study. It plans to enroll approximately 2,000 patients with hypoalbuminemia and\u002For hypovolemia requiring urgent treatment who are scheduled to receive at least one dose of Recombinant Human Albumin from Oryza Sativa. The study does not interfere with clinical diagnosis and treatment; the use of the study drug is solely determined by the attending physician based on the patient's condition and clinical guidelines.\n\nStudy data will be collected during the patient's participation in the study, including baseline characteristics, medical history, concomitant medications, records of study drug administration and reasons for use, serum albumin levels (baseline and end of treatment), adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events of special interest (AESIs). The follow-up period will primarily be conducted via telephone.\n\nThe primary endpoint of the study is the incidence of all adverse drug reactions (ADRs). Secondary endpoints include the incidence of all adverse events (AEs), the incidence of AEs by severity, the incidence of serious adverse events (SAEs), the incidence of adverse events of special interest (AESIs), and the incidence of AEs leading to dose interruption, dose reduction, discontinuation, or death related to Recombinant Human Albumin Injection from Oryza Sativa. Efficacy evaluations include changes in serum albumin concentration before and after treatment and assessment of volume restoration.",[91,26],"Hypoalbuminemia","2026-02-26",{"date":94,"type":31},"2026-03-02",{"date":96,"type":21},"2026-02-24",{"date":98,"type":21},"2026-12-31",{"name":100,"class":38},"Healthgen Biotechnology Corp.",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":17,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":39},"100331210","hemodynamics-monitoring-during-lower-body-negative-pressure-lbnp-induced-controlled-hypovolemia-100331210","NCT03592290","Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia","LBPN","Inclusion Criteria:\n\n\\* Healthy volunteers aged 20-45 with\n\nExclusion Criteria:\n\n* Pregnant women\n* Under 20 years of age\n* Subjects with coronary artery disease, diabetes, epilepsy and hypertension",true,"20 Years","45 Years",{"count":112,"type":21},120,"To monitor the changes in central and peripheral monitors\u002Fwaveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.",[26,115],"Hemodynamic Instability","2026-01-15",{"date":118,"type":31},"2026-01-20",{"date":120,"type":31},"2017-11-15",{"date":122,"type":21},"2027-01",{"name":124,"class":125},"Yale University","OTHER",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":22,"phases":4,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":39},"100616365","comparison-of-ppv-and-lvot-vti-during-passive-leg-raising-to-predict-fluid-responsiveness-100616365","NCT07304661","Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness","Comparison of Pulse Pressure Variation and LVOT VTI-Based Cardiac Output Changes During Passive Leg Raising Maneuver in Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: A Prospective Observational Study","Inclusion Criteria:\n\n1. Adult patients aged ≥18 years\n2. Patients admitted to the intensive care unit receiving mechanical ventilation\n3. Presence of suspected intravascular fluid deficit (hypotension, negative fluid balance, or clinical signs of peripheral hypoperfusion)\n4. Patients in sinus rhythm\n5. Presence of invasive arterial blood pressure monitoring\n6. Adequate echocardiographic window allowing transthoracic echocardiographic measurement of LVOT VTI\n7. Patients ventilated with tidal volume ≥8 mL\u002Fkg (ideal body weight)\n8. Hemodynamically stable enough to allow measurement\n\nExclusion Criteria:\n\n1. Patients under 18 years of age\n2. Presence of atrial fibrillation or significant arrhythmias such as frequent ventricular or atrial ectopy\n3. Severe right ventricular dysfunction or significant tricuspid regurgitation\n4. Advanced aortic valve disease (severe stenosis or severe regurgitation)\n5. Patients with significant spontaneous breathing effort\n6. Patients receiving lung-protective low tidal volume ventilation strategy (\\\u003C8 mL\u002Fkg) due to ARDS\n7. Inadequate echocardiographic window for LVOT VTI assessment\n8. Severe hemodynamic instability during measurement (sudden vasopressor escalation or need for resuscitation)\n9. Patients who refuse to participate or from whom written informed consent cannot be obtained from themselves or a first-degree relative",{"count":134,"type":21},48,"1 Day","Hemodynamic instability remains one of the leading causes of morbidity and mortality among critically ill patients in intensive care units. One major contributor to this instability is intravascular fluid deficit. Although fluid administration is often preferred as an initial intervention, inaccurate estimation of fluid requirements carries significant risks. Inadequate resuscitation may lead to tissue hypoperfusion and organ dysfunction, whereas excessive fluid loading is associated with pulmonary edema, increased intra-abdominal pressure, multi-organ dysfunction, and increased mortality. Consequently, reliable prediction of fluid responsiveness is considered a critical determinant in modern intensive care management.\n\nThe limited reliability of static parameters in predicting fluid responsiveness and the fact that PPV retains its validity only under specific clinical conditions highlight the need for more effective methods. In recent years, hemodynamic changes assessed during the passive leg raising (PLR) maneuver have gained prominence; particularly, left ventricular outflow tract velocity time integral (LVOT VTI)-based cardiac output measurements have been identified as a strong parameter for predicting fluid responsiveness . Moreover, changes in pulse pressure variation (PPV) during PLR have also been reported as a potential predictor; however, the number of studies prospectively comparing PPV variation and LVOT VTI-based cardiac output change within the same patient population remains limited . Therefore, the proposed study aims to fill this gap in the literature and contribute to fluid management in the intensive care setting.\n\nThe aim of this study is to compare the performance of PPV variation and LVOT VTI-based cardiac output change after the PLR maneuver in predicting fluid responsiveness among mechanically ventilated critically ill patients, and to determine the diagnostic value of both methods. The findings of the present study are expected to support more reliable decision-making in fluid therapy and provide clinical evidence toward the individualization of fluid management in intensive care practice.",[115,26,138,139],"Critical Illness","Pulse Pressure Variation",[141,142,139,143,144,145],"Fluid Responsiveness","Passive Leg Raising","LVOT VTI","Cardiac Output","Echocardiography","2025-12-13",{"date":148,"type":31},"2025-12-26",{"date":150,"type":21},"2026-01-01",{"date":152,"type":21},"2027-06-01",{"name":154,"class":125},"Izmir Katip Celebi University",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":162,"targetDuration":135,"studyType":22,"phases":4,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":39},"100616364","role-of-end-tidal-co2-during-passive-leg-raising-to-predict-fluid-responsiveness-in-icu-100616364","NCT07304648","Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU","The Role of End-Tidal Carbon Dioxide Changes During Passive Leg Raising in Predicting Fluid Responsiveness for Mechanically Ventilated Patients in the Intensive Care Unit: A Prospective Observational Study","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patients who have been followed in the intensive care unit (ICU) with mechanical ventilation support for at least 24 hours.\n* Patients for whom a mini fluid challenge (MFC) is clinically planned by the intensive care team.\n* Patients for whom informed consent has been obtained from first-degree relatives or a legal representative.\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age.\n* Pregnant patients.\n* Patients without consent from first-degree relatives or a legal representative.\n* Patients with known deep vein thrombosis (DVT) in the leg veins (risk of embolism during leg raising).\n* Patients with pathologies that may cause increased intracranial pressure (e.g., intracranial mass, hemorrhage).\n* Patients with uncontrolled hypertension.\n* Patients with severe cardiac disease (e.g., right heart failure, pulmonary hypertension, advanced valvular pathology).\n* Patients with carbon dioxide (CO2) retention.\n* Patients who have undergone hip surgery or hip replacement surgery where Passive Leg Raising (PLR) cannot be performed.\n* Patients with spontaneous breathing.\n* Patients with a probability of high intra-abdominal pressure.\n* Patients who cannot lie in a supine position.\n* Patients with current peripheral oxygen saturation (SpO2) \\\u003C 88%.\n* Patients on mechanical ventilation requiring pressure support \\> 16 mmHg or PEEP \\> 10 mmHg.",{"count":163,"type":21},68,"This prospective observational study evaluates whether monitoring changes in exhaled carbon dioxide (End-Tidal CO2 or EtCO2) during a \"Passive Leg Raising\" (PLR) test can reliably predict fluid responsiveness in critically ill patients.\n\nIn the Intensive Care Unit (ICU), fluid management is a critical balance; while fluid is necessary for tissue perfusion, overload can lead to severe complications. Traditional static measurements (like central venous pressure) are often unreliable for guiding therapy. Dynamic tests like PLR are preferred as they simulate a fluid bolus reversibly by shifting blood from the legs to the heart.\n\nResearchers will observe mechanically ventilated patients planned for fluid resuscitation. The study compares the accuracy of non-invasive EtCO2 changes during PLR against a reference standard \"Mini Fluid Challenge\" (100 mL fluid administration). Fluid responsiveness will be confirmed using echocardiographic measurements (LVOT-VTI) or arterial pressure changes. The goal is to validate EtCO2 as a practical, real-time tool for safe fluid management.",[166,138,26],"Circulatory Failure",[141,142,168,169,170,171],"End-Tidal CO2","Mini Fluid Challenge","Mechanical Ventilation","Intensive Care",{"date":148,"type":31},{"date":150,"type":21},{"date":175,"type":21},"2027-07-01",{"name":154,"class":125},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":18,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":39},"100608836","ivc-ultrasound-versus-central-venous-pressure-for-early-detection-of-hypovolemia-in-shock-patients-100608836","NCT07206732","IVC Ultrasound Versus Central Venous Pressure for Early Detection of Hypovolemia in Shock Patients","Ultrasound-Guided Inferior Vena Cava Assessment Versus Central Venous Pressure Monitoring in Early and Post-Resuscitation Detection of Hypovolemia Among Shocked Patients in the Emergency Department","Inclusion Criteria:\n\n1- Adult patients aged ≥18 years. 2.Both male and female patients will be included in the study. 3. Presentation to the Emergency Department with clinical evidence of shock, defined by: Hypotension (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg).\n\nEvidence of tissue hypoperfusion (e.g., altered mental status, cold extremities, or oliguria).\n\nElevated serum lactate (\\>2 mmol\u002FL). 4. Shock attributed to hypovolemic, septic, or hemorrhagic etiologies. 5. Patients requiring fluid resuscitation and hemodynamic monitoring.\n\nExclusion Criteria:\n\n1 - Patients younger than 18 years. 2. Pregnancy. 3.Cardiogenic or obstructive shock (e.g., cardiac tamponade, massive pulmonary embolism, or tension pneumothorax).\n\n4.Known inferior vena cava (IVC) anomalies (e.g., congenital absence, thrombosis).\n\n5\\. Increased intra-abdominal pressure or severe ascites. 6. Morbid obesity (BMI ≥40 kg\u002Fm²) or any condition interfering with adequate IVC ultrasound visualization.\n\n7\\. Prior central venous catheterization performed before Emergency Department arrival.\n\n8\\. Congestive heart failure (CHF) with left ventricular ejection fraction (LVEF \\\u003C40%) or pulmonary hypertension.\n\n9\\. Refusal of the patient or legal guardian to participate in the study.",{"count":185,"type":21},80,"This study aims to compare ultrasound-guided inferior vena cava (IVC) assessment with central venous pressure (CVP) monitoring for the detection of hypovolemia in shock patients in the emergency department. The primary objective is to evaluate the diagnostic accuracy and clinical utility of IVC collapsibility index compared to CVP values in both early and post-resuscitation phases. The study will prospectively enroll shock patients, collect demographic and clinical data, and analyze the correlation between IVC and CVP measurements to determine their role in guiding fluid resuscitation and hemodynamic management.",[188,26,166],"Shock",[188,26,190,191,192,193],"Emergency department","Central venous pressure","Fliud resuscitation","Ultrasound guided IVC","2025-11-16",{"date":196,"type":31},"2025-11-19",{"date":198,"type":21},"2025-12-15",{"date":200,"type":21},"2026-12-15",{"name":202,"class":125},"Assiut University",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":39},"100536303","hemodynamic-monitoring-during-craniosynostosis-surgery-comparing-traditional-and-newer-technology-monitors-crasy-pram-100536303","NCT06263075","Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)","Evaluation of the Hemodynamic Variability During Craniosynostosis Surgery: a Comparison Between Traditional Hemodynamic Monitoring and Pressure Recording Analytic Method (CRASY-PRAM)","CRASY-PRAM","Inclusion Criteria:\n\n* Infants with craniosynostosis undergoing corrective surgery\n* Ages between 3 and 8 months\n* Physical status classification of the American Society of Anesthesiologists (ASA) \\\u003C\u002F= 2\n* Consent obtained from the patients' parents\u002Flegal guardians\n\nExclusion Criteria:\n\n* Congenital or acquired cardiac disease\n* Preoperative cardiac dysfunction\n* Metabolic diseases\n* Gestational age at birth \\\u003C30 weeks\n* Body weight less than 3 kg\n* Dislocation or malfunction of the arterial catheter\n* Malfunctioning of monitoring devices","3 Months","8 Months",{"count":214,"type":21},30,"Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.\n\nSurgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.\n\nThis study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.",[217,26,218,115],"Craniosynostoses","Hemorrhage",[220,221],"Monitoring Physiologic","Monitoring Intraoperative","2025-09-30",{"date":224,"type":31},"2025-10-03",{"date":226,"type":31},"2023-12-13",{"date":228,"type":21},"2026-06",{"name":230,"class":125},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":241,"phases":242,"briefSummary":244,"conditions":245,"keywords":252,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100510835","phase-3-early-initiated-vasopressor-therapy-in-the-emergency-department-100510835","NCT05931601","Early Initiated Vasopressor Therapy in the Emergency Department","Early Initiated Vasopressor Therapy vs. Standard Care of Primarily Fluid Therapy in Hypotensive Patients in the Emergency Department - A Pragmatic, Multi-center, Superiority, Randomized Controlled Trial","VASOSHOCK","Inclusion Criteria:\n\n* At least 18 years of age\n* Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as:\n\n  1. SBP \\\u003C 100mmHg or MAP \\\u003C 65 mmHg combined with lactate \\> 2.0 mmol\u002FL,\n  2. Physician defined blood pressure for the individual patient combined with a lactate \\> 2.0 mmol\u002FL\n  3. Either SBP \\\u003C 100mmHg or MAP \\\u003C 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician.\n* Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival.\n* Clinical Frailty Score (CFS) of ≤4. If CFS is ≥5 and the treating physician find the patient suitable for ICU admittance, the participant can be enrolled, if the on-call ICU doctor would accept the patient for ICU admittance. If the treating physician is unsure of ICU eligibility, regardless of CFS score, the patient should be consulted with the ICU consultant before study inclusion.\n\nExclusion Criteria:\n\n* Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.\n* Fertile women (\\\u003C60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding.\n* Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant.\n* Known allergy to noradrenaline.",{"count":240,"type":21},320,"INTERVENTIONAL",[243],"PHASE3","The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish and Swedish Emergency Departments (ED).\n\nThe main questions it aims to answer are:\n\nIf early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can\n\n* Improve time to shock control.\n* Reduce the need for ICU admittance.\n* Decrease mortality.\n\nParticipants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay.\n\nAfter completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers.\n\nPatients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves.\n\nResearchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish and Swedish Emergency Departments.",[188,246,247,248,249,26,250,251],"Shock, Septic","Hypotension","Hypotension and Shock","Hypotension Symptomatic","Hypovolemic Shock","Hypovolemic",[253,254,255,256,257],"Peripherally infused noradrenaline","Fluid therapy","Fluid treatment","Non-hemorrhagic shock and hypotension","Emergency Department","2025-06-26",{"date":260,"type":31},"2025-07-01",{"date":262,"type":31},"2023-12-08",{"date":264,"type":21},"2027-01-31",{"name":266,"class":125},"Odense University Hospital",8,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":241,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100521656","phase-3-a-phase-iii-open-label-randomized-controlled-study-of-vbi-s-in-the-treatment-of-hypovolemia-in-patients-with-septic-shock-vbi-s-02-100521656","NCT06072430","A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)","A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock","VBI-S-02","Inclusion Criteria:\n\n1. Male or female at least 18 years of age.\n2. Evidence of bacterial infection demonstrated by positive blood culture and\u002For a known source of infection and\u002For an elevated procalcitonin of ≥ 2 ng\u002Fml.\n3. Patient has a mean blood pressure \\\u003C 65 mmHg that is unresponsive to fluids currently available on the market.\n4. Sequential Organ Failure Assessment (SOFA) score ≥ 5\n5. Sepsis diagnosis: The presence of infection which can be proven or suspected by 2 or more of the following criteria:\n\n   * Lactate \\> 2 mmol\u002FL\n   * Fever \\> 38.3°C, or 101°F\n   * Hypothermia \\\u003C 36°C core temperature (\\\u003C96.8°F)\n   * Heart rate \\> 90\n   * Tachypnea (respiratory rate ≥ 20\u002Fmin)\n   * White blood cell count \\>12,000 or less than 4,000, or with \\>10% \"bands\" (immature forms)\n   * Elevated procalcitonin in serum (≥ 2ng\u002Fml)\n   * Arterial hypoxemia (PaO2\u002FFiO2 \\\u003C 300)\n   * Creatinine increase \\> 0.5 mg\u002FdL since hospital admission\n   * INR \\> 1.5 or aPTT \\> 60 seconds\n6. Documented dysregulated host response to an infection as indicated by an increase in SOFA score by ≥ 2 points after an infection per the SEPSIS 3 guideline.\n7. Receiving vasopressors to maintain the target MAP of 65 mmHg.\n\nExclusion Criteria:\n\n1. Patients with a ventricular assist device\n2. Acute coronary syndrome\n3. Pregnant\n4. Acute bronchospasm\n5. Acute Mesenteric ischemia\n6. Emergency major surgery\n7. Diagnosis of acute Hepatitis B or C.\n8. Hematologic or coagulation disorders including thrombocytopenia (platelet count \\\u003C50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.\n9. White blood cell count of \\\u003C 1000 mm3\n10. Current participation or participation in another experimental or device study within the last 30 days before the start of this study. Patient may be included if on other drugs are for COVID-19.\n11. Patients with a known allergy to soybeans or eggs\n12. Patient is hypervolemic with assessment by physician or physician extender ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.\n13. Patient expected to expire within 12 hours.\n14. Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.",{"count":277,"type":21},46,[243],"This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.",[281,282,26],"Septic Shock","Sepsis","2025-04-03",{"date":285,"type":31},"2025-04-04",{"date":287,"type":31},"2024-08-06",{"date":289,"type":21},"2025-12",{"name":291,"class":38},"Vivacelle Bio",6]