NCT07232342招募中不适用
Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- all-cause mortality
研究概览
简要总结
This study aims to evaluate the prognostic significance of CLI in predicting 28-day mortality and other outcomes in critically ill patients who develop post-operative abdominal sepsis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Postoperative secondary peritonitis requiring ICU admission, with clinical evidence of:
- •Diffuse or localized abdominal pain/tenderness. Peritoneal signs (e.g., guarding, rigidity, rebound tenderness). Imaging or intraoperative confirmation of purulent/exudative intra-abdominal fluid.
- •Systemic inflammation (e.g., fever, leukocytosis, or vasopressor requirement). Sepsis diagnosis per Sepsis-3 criteria: Suspected/confirmed infection with acute increase in SOFA score ≥2 points (6).
- •Anticipated ICU stay ≥48 hours postoperatively.
排除标准
- •Pregnancy
- •Advanced liver disease (Child-Pugh class B or C) that might independently affect albumin levels
- •Advanced kidney disease (CKD stage 4 or 5) or patients on chronic dialysis
- •Expected mortality within 48 hours of ICU admission
- •Patients with primary peritonitis or tertiary peritonitis
- •Immunocompromised patients (e.g., on chronic immunosuppressive therapy, solid organ transplant recipients, patients with HIV and CD4 count <200/mm³)
- •Patients with pre-existing systemic inflammatory diseases that might affect baseline CRP levels
- •Patients participating in interventional trials that might affect outcomes
结局指标
主要结局
all-cause mortality
时间窗: From 1-10-2025 to 1-10-2026
次要结局
未报告次要终点
研究者
Samar Rafik Mohamed Amin
Dr
Benha University
研究点 (1)
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