About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock
Eligible for blood sampling during daytime hours
Adults admitted to the postoperative ICU within 24 hours after surgery
Need for fluid resuscitation
Disqualifiers
- 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
Trial design
Parallel
Treatments tested in this trial
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.
Other interventionA 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.
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.
Other interventionDescription: 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
Treatment groups
Trial outcomes
Primary outcomes
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock.
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock.
Secondary outcomes
Correlation coefficient between CLI at Day 0 and extracellular water accumulation from Day 0 to Day 3, assessed by bioimpedance, in patients with septic shock
Correlation coefficient between CLI at Day 0 and extracellular water accumulation from Day 0 to Day 3, assessed by bioimpedance, in patients with septic shock
Difference in CLI at Day 0 between patients with septic shock and those without.
Difference in CLI at Day 0 between patients with septic shock and those without.
Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.
Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.
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