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

NCT07733206 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-29

No results posted yet for this study

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

Interventions

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.

A standardised fluid bolus of 8 mL/kg 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: CLI = (Hb pre - Hb post) / Hb pre \* 100 In selected patients, extracellular water volume will be estimated using bioimpedance analysis.

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.

Description: A standardised fluid bolus of 8 mL/kg 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) / Hb pre \* 100

Sponsors & Collaborators

  • University Hospital Center of Martinique

    lead OTHER

Principal Investigators

  • PATRICK ROYER, DR · CHU MARTINIQUE

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2028-10-15
Completion
2028-10-15

Countries

  • Martinique

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733206 on ClinicalTrials.gov