[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649448":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":57,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":24,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":87,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital Center of Martinique","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TEST GROUP","EXPERIMENTAL","Septic shock patients receiving standardised fluid resuscitation, with CLI computation, biomarker analysis (angiopoietin-2 and syndecan-1), and extracellular water evaluation using bioimpedance.",[13],"Other: TEST GROUP: A standardised fluid bolus of 8 mL\u002Fkg of ideal body weight using Ringer's lactate will be administered in septic shock patients.",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group:","Postoperative patients undergoing standardised fluid resuscitation, CLI computation and biomarker analysis (angiopoietin-2 and syndecan-1)",[18],"Other: CONTROL GROUP: A standardised fluid bolus of 8 mL\u002Fkg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"TEST GROUP: A standardised fluid bolus of 8 mL\u002Fkg of ideal body weight using Ringer's lactate will be administered in septic shock patients.","A standardised fluid bolus of 8 mL\u002Fkg of ideal body weight using Ringer's lactate will be administered in septic shock patients. Haemoglobin levels will be measured before and after the infusion, and CLI will be calculated using the following formula:\n\nCLI = (Hb pre - Hb post) \u002F Hb pre \\* 100 In selected patients, extracellular water volume will be estimated using bioimpedance analysis.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"CONTROL GROUP: A standardised fluid bolus of 8 mL\u002Fkg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.","Description: A standardised fluid bolus of 8 mL\u002Fkg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients. Haemoglobin levels will be measured before and after the infusion, and CLI will be calculated using the following formula: CLI = (Hb pre - Hb post) \u002F Hb pre \\* 100",[15],[30],{"name":31,"affiliation":32,"role":33},"PATRICK ROYER, DR","CHU MARTINIQUE","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"SARAH-PRESCILLIA JOSEPH, MSC","CONTACT","0596592696","+596","SARAH-PRESCILLIA.JOSEPG@CHU6MARTINIQUE.FR",[42],{"facility":43,"status":24,"city":44,"state":45,"zip":46,"country":45,"countryCode":24,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CHUM","Fort-de-France","Martinique","97261",{"type":48,"coordinates":49},"Point",[50,51],-61.07418,14.60365,{"lat":51,"lon":50},[54,56],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":55},"SARAH-PRESCILLIA.JOSEPH@CHU-MARTINIQUE.FR",{"name":31,"role":33,"phone":24,"phoneExt":24,"email":24},{"type":58,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100649448","validation-of-a-capillary-leak-index-during-septic-shock-based-on-haemoglobin-level-variations-induced-by-fluid-resuscitation-a-pilot-study-100649448",false,"NCT07733206","Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.","IFC-sepsis","Inclusion Criteria:\n\n* Test group (septic shock patients):\n* Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock\n* Eligible for blood sampling during daytime hours\n\nControl group (non septic shock patients):\n\n* Adults admitted to the postoperative ICU within 24 hours after surgery\n* Need for fluid resuscitation\n* Eligible for blood sampling during daytime hours\n* Patients with an arterial catheter in place as part of their care\n\nExclusion Criteria:\n\n* \\- Clarkson's disease (idiopathic capillary leak syndrome)\n* Pre-existing extracellular fluid overload (e.g., cirrhosis, decompensated heart failure, nephrotic syndrome, chronic kidney disease on or awaiting dialysis)\n* Active bleeding or hemolysis\n* Receiving ECMO\n* Ongoing renal replacement therapy during the intervention\n* Blood transfusion within one hour before the intervention\n* Change in vasopressor or inotrope dose within 30 minutes before the intervention","ALL","18 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study aims to validate a simple and reproducible index of capillary leak (CLI) in septic shock, based on haemoglobin (Hb) variation induced by standardised fluid resuscitation. To achieve this, the correlation between CLI and biomarkers of endothelial dysfunction-angiopoietin-2 and syndecan-1-will be assessed in both septic and non-septic shock patients. CLI may contribute to the individualisation of fluid management in patients with septic shock.",[76],"Sepsis",[78,79,80,81,82,83,84,85,86],"Septic shock","capillary leak","endothelial dysfunction","angiopoietin-2","syndecan-1","fluid resuscitation","haemoglobin variation","extracellular water","bio-impedance","NOT_YET_RECRUITING","2026-07-28",{"date":90,"type":91},"2026-07-29","ACTUAL",{"date":93,"type":70},"2026-09-15",{"date":95,"type":70},"2028-10-15",{"name":5,"class":6},1]