Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study. | NCT07733206

NCT07733206

Overview

NCT ID: NCT07733206
Lead Sponsor: University Hospital Center of MartiniqueOTHER
Official Title: Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.
Brief Summary: 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.
Conditions: Sepsis
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Sep 15, 2026Estimated
Primary Completion Date: Oct 15, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Test group (septic shock patients):

Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock

Eligible for blood sampling during daytime hours

Control group (non septic shock patients):

Adults admitted to the postoperative ICU within 24 hours after surgery

Need for fluid resuscitation

Eligible for blood sampling during daytime hours

Patients with an arterial catheter in place as part of their care

Exclusion Criteria:

- Clarkson's disease (idiopathic capillary leak syndrome)

Pre-existing extracellular fluid overload (e.g., cirrhosis, decompensated heart failure, nephrotic syndrome, chronic kidney disease on or awaiting dialysis)

Active bleeding or hemolysis

Receiving ECMO

Ongoing renal replacement therapy during the intervention

Blood transfusion within one hour before the intervention

Change in vasopressor or inotrope dose within 30 minutes before the intervention

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 100Estimated
Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: SARAH-PRESCILLIA JOSEPH, MSCContact
SARAH-PRESCILLIA.JOSEPG@CHU6MARTINIQUE.FR

Similar Studies

Participant Group/Arms

TEST GROUPExperimental

Septic shock patients receiving standardised fluid resuscitation, with CLI computation, biomarker analysis (angiopoietin-2 and syndecan-1), and extracellular water evaluation using bioimpedance.

Other: TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients.

Control group:Other

Postoperative patients undergoing standardised fluid resuscitation, CLI computation and biomarker analysis (angiopoietin-2 and syndecan-1)

Other: CONTROL GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.