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Completed
NCT07232342
Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes
Conditions: Peritonitis Infectious
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Benha University
Location: Benha University Hospital Banhā Qalyubia Governorate
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 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 \
Source: ClinicalTrials.gov (NCT07232342). StuddyBuddy aggregates publicly available trial information.