Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Septic shock is characterised by systemic inflammation leading to endothelial dysfunction and increased capillary permeability. This results in intravascular hypovolaemia and interstitial oedema, contributing to tissue hypoperfusion and organ failure. Despite the prognostic implications, bedside assessment of capillary leak remains difficult, with no simple or standardised method available. Fluid resuscitation is the first-line therapy for circulatory failure in septic shock, but excessive fluid administration has been associated with increased mortality. Recent trials investigating restrictive fluid strategies have failed to show a survival benefit, likely due to the lack of patient stratification based on the severity of capillary leak. A bedside marker could guide personalised fluid and vasopressor therapy.
A standardised fluid bolus (8 ml/kg of ideal body weight, Ringer's lactate) will be administered in both septic and non-septic shock patients. Haemoglobin levels will be measured before and after infusion, and the CLI will be calculated as (Hb pre - Hb post) / Hb pre * 100. Bioimpedance analysis will be used to estimate extracellular water in selected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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
结局指标
主要结局
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.
时间窗: 04 DAYS
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.
次要结局
- 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(04 DAYS)
- Difference in CLI at Day 0 between patients with septic shock and those without.(01 DAY)
- Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.(30 DAYS)