Capillary Leak Index to predict outcomes after postoperative abdominal sepsis
Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes
This test checks whether the Capillary Leak Index predicts 28-day outcomes better than standard blood markers for adults in the ICU after postoperative abdominal sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Qalyubia Governorate) |
| Trial ID | NCT07232342 on ClinicalTrials.gov |
What this trial studies
This is a single-center observational cohort of adults with postoperative secondary peritonitis requiring ICU admission who meet Sepsis-3 criteria. Researchers will compare the Capillary Leak Index to conventional biomarkers collected early in the ICU course to see which better predicts 28-day mortality and other clinical outcomes. Patients with advanced liver or kidney disease, pregnancy, primary/tertiary peritonitis, or severe immunosuppression are excluded. All enrolled patients will be treated at Benha University Hospital and followed during their ICU stay and for 28 days post-enrollment.
Who should consider this trial
Good fit: Adults (age ≥18) with postoperative secondary peritonitis admitted to the ICU who meet Sepsis-3 criteria and are expected to stay in the ICU at least 48 hours.
Not a fit: Patients who are pregnant, have advanced liver (Child-Pugh B/C) or advanced kidney disease (CKD stage 4–5) or on chronic dialysis, have primary/tertiary peritonitis, are immunocompromised, or are expected to die within 48 hours are excluded and unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, the Capillary Leak Index could help clinicians identify high-risk patients earlier and guide more targeted monitoring or treatment to reduce complications and deaths.
How similar studies have performed: Prior observational work using capillary leak–related measures (for example CRP/albumin ratios and related indices) has shown promising associations with sepsis severity and mortality, but the approach remains relatively novel and not yet standard practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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
Where this trial is running
Banhā, Qalyubia Governorate
- Benha University Hospital — Banhā, Qalyubia Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.