[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sepsis---to-reduce-mortality-in-the-intensive-care-unit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sepsis---to-reduce-mortality-in-the-intensive-care-unit":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,79,111,140,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641525","phase-4-efficacy-and-safety-of-oral-nicotinamide-as-an-adjunctive-therapy-in-patients-with-sepsis-100641525",false,"NCT07655791","Efficacy and Safety of Oral Nicotinamide as an Adjunctive Therapy in Patients With Sepsis","Evaluation of the Efficacy and Safety of Oral Nicotinamide as an Adjunctive Therapy in Patients With Sepsis","Inclusion Criteria:\n\n* Patients older than 18 years of any gender who were admitted to the intensive care unit\n* Diagnosed as sepsis patient with the Sequential Organ Failure Assessment (SOFA) Score described as an Increase in SOFA score ≥2 points due to infection.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients who had already been taking antioxidant supplements before recruiting.\n* Patient with contraindications or reported allergies to Nicotinamide.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Sepsis is a severe, life-threatening condition caused by an abnormal host response to infection, which includes systemic inflammation, oxidative stress, and increasing organ dysfunction. It is frequently associated with bacterial, viral, fungal, or parasite infections, as well as non-infectious illnesses like trauma and pancreatitis. It remains a primary cause of mortality in hospitals, with rates nearing 40% in severely ill patients. pathophysiological, excessive cytokine release (e.g., TNFα, IL-6, IL-1β) and reactive oxygen\u002Fnitrogen species lead to mitochondrial injury, immunosuppression, and multiple organ failure. Sepsis diagnosis is guided byNEWS2 \\& a SOFA score ≥2, hypotension, and elevated lactate, while worsening SOFA scores predict poor outcomes. Standard management focusses on early antibiotic therapy, fluid resuscitation, and vasoactive support. Standard anti-inflammatory methods using steroidal or non-steroidal medicines may show little efficacy to improve the patient's clinical outcomes. Adjunctive antioxidant therapies, including vitamins C and E, NAC, and melatonin, have demonstrated reductions in oxidative stress and organ dysfunction. Nicotinamide (NAM) (vitamin B3), a precursor of NAD+\u002FNADP+ critical for energy metabolism and cellular repair, has emerged as a potential therapeutic candidate due to its ability to attenuate cytokine production, modulate immune responses, and mitigate oxidative damage. Usual dose of NAM (500mg-1500mg per day) is generally safe. A dose of 1000 mg was found to be safe and effective in reducing the circulating inflammatory cytokines showing a good profile as an anti-inflammatory adjunct therapy. Higher than usual NAM dose can increase the likelihood of adverse effects, such as diarrhea, increased liver enzymes (rarely occurring at doses exceeding 3 grams per day), symptoms of thrombocytopenia (including increased bruising and bleeding), and stomach upset.\n\nSince the role of NAM as adjunct therapy in sepsis management is not yet established, further large-scale clinical studies are recommended to establish its efficacy and safety in sepsis management.\n\nThe aim of our study is to evaluate the efficacy and safety of the addition of Nicotinamide (1000mg oral tablet) as an adjunct therapy to improve the outcome of septic patients.",[26],"Sepsis - to Reduce Mortality in the Intensive Care Unit",[28,29,30,31,32,33],"Sepsis","IL-6","NF-kB","anti-inflammatory","Nicotinamide","Mortality","NOT_YET_RECRUITING","2026-06-13",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":20},"2026-07-01",{"date":42,"type":20},"2027-01-01",{"name":44,"class":45},"Ain Shams University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100606724","veno-arterial-carbon-dioxide-partial-pressure-difference-co2gap-for-early-resuscitation-of-septic-shock-100606724","NCT07179276","Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock","Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock: A Multicenter Prospective Randomized Trial (CARBON)","CARBON","Inclusion Criteria:\n\n* Patients aged 18 years or older AND\n* Acutely admitted to a study ICU AND\n* Primary diagnosis of septic shock according to the Sepsis-3 criteria and defined as:\n\n  * A suspected or documented site of infection or positive blood culture AND\n  * Acute increase of at least 2 points in the Sequential Organ Failure Assessment (SOFA) score consequent to the infection AND\n  * Having a serum lactate level \\>2 mmol\u002Fl AND\n  * Requirement of vasopressors (any dose of norepinephrine) to maintain mean arterial pressure (MAP) ≥65 mmHg despite adequate fluid resuscitation (at least 1L of IV fluid in the last 24 hours prior to screening)\n\nExclusion Criteria:\n\n* Septic shock for more than 12 hours at the time of screening\n* Primary cause of hypotension not due to sepsis (e.g., acute bleeding)\n* Decision not to resuscitate (or to limit full care) or not to intubate taken before obtaining consent\n* Death is deemed to be imminent or inevitable or patients with an underlying disease process with a life expectancy of less than 3 months\n* Anticipated surgery during the first 24 hours after randomization\n* Patient or their relatives' refusal to participate\n* Patients participating in another RCT with interventions possibly compromising the primary outcome\n* Prior enrollment in the CARBON trial\n* Known to be pregnant.\n* Legal protection (i.e., incompetence to provide consent and no guardian or incarceration)\n* No affiliation with the French health care system",{"count":56,"type":20},750,[58],"NA","Sepsis is a dysregulated host response to infection that leads to life-threatening organ dysfunction and represents a major healthcare problem. Septic shock is the most severe form, characterized by increased capillary permeability and vasodilation, resulting in hypotension and tissue hypoxia. Early identification and treatment of tissue hypoperfusion are pivotal components of initial resuscitation to limit progression to multiple organ dysfunction and death. The 2021 Surviving Sepsis Guidelines recommend guiding initial resuscitation by targeting decreases in serum lactate levels in patients with elevated lactate. However, although elevated lactate levels may reflect tissue hypoxia, serum lactate is not a direct marker of tissue perfusion. Hyperlactatemia may be attributable to mechanisms other than tissue hypoperfusion, such as accelerated aerobic glycolysis driven by excessive β-adrenergic stimulation or impaired clearance (e.g., in liver failure).\n\nThe venous-to-arterial carbon dioxide partial pressure difference (CO₂ gap), which is inversely related to cardiac output, has been shown to reflect the adequacy of venous blood flow to remove CO₂ from tissues. The CO₂ gap is closely linked to microcirculatory blood flow during the early resuscitation phase of septic shock and may effectively identify persistent tissue hypoperfusion in shock states. A persistently high CO₂ gap during early resuscitation has been associated with significantly higher 28-day mortality and increased Sequential Organ Failure Assessment (SOFA) scores. Moreover, the CO₂ gap has been shown to respond to changes in cardiac output during inotrope infusion in patients with low blood flow, suggesting that its assessment could be useful for therapeutic adjustments. Therefore, there are compelling arguments to evaluate the usefulness of the CO₂ gap in guiding early resuscitation in patients with septic shock.\n\nThe investigators postulated that CO₂ gap-guided early resuscitation may be more effective in improving outcomes than lactate-guided resuscitation.",[26,61],"Septic Shock",[63,64,65,66,67],"lactate","CO2 gap","resuscitation strategie","sepsis","hemodynamic therapy","RECRUITING","2026-06-12",{"date":71,"type":38},"2026-06-15",{"date":73,"type":38},"2026-03-29",{"date":75,"type":20},"2027-12-31",{"name":77,"class":45},"University Hospital, Clermont-Ferrand",28,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100627688","phase-2-adjunctive-fludrocortisone-in-septic-shock-100627688","NCT07451886","Adjunctive Fludrocortisone in Septic Shock","Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)","AFLUDROS-1","Inclusion Criteria:\n\n1. suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection\n2. ≥0.25 μg\u002Fkg\u002Fmin of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour\n3. onset of septic shock within 24 hours\n4. shock due to infection with no other proven or apparent cause\n5. hypoperfusion defined as arterial or venous lactate concentration \\>2.0 mmol\u002FL\n6. mechanical ventilation\n\nExclusion Criteria:\n\n1. fludrocortisone cannot be administered within 24 hours of onset of septic shock\n2. death is deemed imminent or inevitable by treating clinicians\n3. limitation of therapy\n4. an underlying disease process with a life expectancy of less than 90 days\n5. pregnancy (confirmed or suspected)\n6. receiving immunomodulatory agents including hydrocortisone \\> 300mg\u002Fday\n7. enteral medication cannot be administered\n8. prescribed fludrocortisone for other medical condition\n9. contraindication to hydrocortisone or fludrocortisone",{"count":88,"type":20},32,[90],"PHASE2","Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone.\n\nTo test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.",[28,61,26,93,94],"Sepsis and Septic Shock","Sepsis at Intensive Care Unit",[96,97,28,98,99,100],"Fludrocortisone","Septic shock","hydrocortisone","intensive care unit","pilot","2026-06-01",{"date":103,"type":38},"2026-06-02",{"date":105,"type":38},"2026-04-01",{"date":107,"type":20},"2028-07-31",{"name":109,"class":45},"Chinese University of Hong Kong",5,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":121,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100602673","evaluating-the-accuracy-of-multiple-blood-tests-to-diagnose-sepsis-in-adult-burn-patients-100602673","NCT07126574","Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients","Research Protocol for Evaluating the Diagnostic Utility of SAA, Procalcitonin, Presepsin, CRP, and Routine Blood Biomarkers in Adult Burn Patients With Sepsis in the Intensive Care Unit","BioBurnSepsis","Inclusion Criteria:\n\n* Age 18 years or older.\n* Admission to the Burn Intensive Care Unit (BICU) with a burn injury covering ≥10% of the Total Body Surface Area (TBSA).\n* Undergoing a blood culture due to clinical suspicion of sepsis (e.g., fever, abnormal white blood cell count, hemodynamic instability) during the ICU stay.\n* The participant or their legally authorized representative has provided written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Pre-existing immunological conditions that, in the investigator's judgment, could interfere with biomarker interpretation (e.g., long-term use of immunosuppressants, congenital immunodeficiency).\n* Inability to participate at the time of study-related blood collection due to initial emergency surgery, major trauma, or significant hemorrhage.\n* Any other condition for which the principal investigator deems participation to be inappropriate or unsafe for the patient.",{"count":120,"type":20},165,"1 Year","OBSERVATIONAL","This prospective diagnostic accuracy study evaluates the performance of presepsin and C-reactive protein (CRP) as early biomarkers for suspected sepsis in adult burn patients. From January 2021 to December 2022, 370 patients with ≥20% total body surface area burns admitted to the Burn Intensive Care Unit at Hallym University Hangang Sacred Heart Hospital were screened; 221 met inclusion criteria. At each clinical suspicion of sepsis (≥2 SIRS criteria), venous blood was drawn for simultaneous measurement of presepsin (via chemiluminescent immunoassay) and CRP (via immunoturbidimetric assay). Diagnostic accuracy will be quantified by sensitivity, specificity, positive\u002Fnegative predictive values, and area under the ROC curve. The goal is to determine whether presepsin outperforms CRP for early sepsis detection in severe burn patients.",[26,125],"Burns Involving 20% or More of Body Surface",[127,128,129,130],"presepsin","diagnostic accuracy","biomarker evaluation","Serum Amyloid A","2025-08-10",{"date":133,"type":38},"2025-08-17",{"date":135,"type":20},"2025-08-15",{"date":137,"type":20},"2026-10-31",{"name":139,"class":45},"Dohern Kym",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":46},"100584611","rotem-in-sepsis-trauma-outcome-in-intensive-care-100584611","NCT06891599","ROTEM in Sepsis Trauma Outcome in Intensive Care","Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)","ROSTIC","Inclusion Criteria:\n\nTrauma patients:\n\nTrauma alarm activated at hospital admission New Injury Severity Score (NISS) \\> 15 Transfer to hospital within 7 days of trauma with NISS \\> 15\n\nSepsis patients:\n\nMeeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission\n\nControl group:\n\nPatients undergoing elective surgery without expected coagulopathy\n\nExclusion Criteria:\n\nTrauma patients:\n\nIsolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age \\\u003C18 years\n\nSepsis patients:\n\nAge \\\u003C18 years\n\nControl patients:\n\nOngoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age \\\u003C18 years",{"count":149,"type":20},600,"This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.",[26,152],"Trauma Coagulopathy",[28,154,155,156],"ROTEM","Trauma","Coagulopathy","2025-03-20",{"date":159,"type":38},"2025-03-24",{"date":161,"type":38},"2024-11-01",{"date":163,"type":20},"2026-12-31",{"name":165,"class":166},"Region Stockholm","OTHER_GOV",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":46},"100574990","phase-4-beta-lactam-antibiotics-initial-exposure-optimised-in-critically-ill-patients-with-sepsis-100574990","NCT06766461","Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis","BULLSEYE","Inclusion Criteria:\n\n* ≥18 years of age\n* Receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics)\n* Primary infection\n* Admitted to the ICU\n* Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mmHg or greater, and a serum lac tate level greater than 2.0 mmol\u002FL following \"adequate fluid resuscitation\".\n\nExclusion Criteria:\n\n* Patient or legal representative not available to give informed consent within 72 hours after admittance\n* Pregnancy\n* Admittance for burn wounds\n* Patients receiving target antibiotics only as prophylaxis within the context of Selective Diges tive tract Decontamination (SDD)\n* Enrolment in another interventional trial\n* Patient received the study antibiotic for more than 24 hours before inclusion\n* Patient receiving extracorporeal membrane oxygenation (ECMO)\n* Patient is already treated with a double dose of antibiotics based on suspected infection",{"count":175,"type":20},980,[23],"The aim of this study is to investigate if an initial short double dose of beta-lactam antibiotics will reduce mortality in critically ill patients with sepsis.",[26,28,61],[66,180,181,182,183],"intensive care","critically ill","antibiotic","septic shock","2025-01-08",{"date":186,"type":38},"2025-01-09",{"date":188,"type":38},"2025-01-03",{"date":190,"type":20},"2027-12-01",{"name":192,"class":45},"Erasmus Medical Center"]