RecruitingNCT07232342
Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes
Sponsor
Benha University
Enrollment
100 participants
Start Date
Dec 10, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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.
Exclusion Criteria8
- 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
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Interventions
DIAGNOSTIC_TESTCapillary Leak Index Versus
Blood samples will be collected at three time points: within 1-2 hours of ICU admission (Day 0), Day 1, Day 2 and Day 7, to monitor trends in CLI and conventional biomarkers during the ICU stay. • CR
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07232342