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CompletedNCT07232342Updated Oct 20, 2026

Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes

An observational study in Peritonitis Infectious, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Benha University · Observational

Updated Oct 20, 2026Now CompletedStudy completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peritonitis Infectious

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Keywords

  • Peritonitis
  • Capillary Leak Index
  • Conventional Biomarkers
  • Critically Ill Patients
03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's enrollment of 100 is below the median of 137 across 55 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay of at least 48 hours will be enrolled.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnancy

    • Advanced liver disease ( 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
    • patients (e.g., on chronic immunosuppressive therapy, solid organ transplant recipients, patients with and \<200/mm³)
    • Patients with pre-existing systemic inflammatory diseases that might affect baseline CRP levels
    • Patients participating in interventional trials that might affect outcomes
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay o

    Diagnostic Test: Capillary Leak Index Versus

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

06

What researchers measure

Primary outcomes

  1. all-cause mortality

    Time frame: From 1-10-2025 to 1-10-2026

07

Study locations

1 site
  • Benha University Hospital
    Banhā, Qalyubia Governorate 13511, Egypt
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 20, 2026
Study completion
Oct 30, 2026→Oct 15, 2026 (actual)
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Completed
    Study completion Oct 30, 2026→Oct 15, 2026 (now actual)
    + 2 other changes: site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07232342
Lead sponsor
Benha University
Responsible party
Samar Rafik Mohamed Amin (Dr, Benha University) — Principal investigator
First posted
Nov 18, 2025
Start date
Dec 10, 2025
Primary completion
Oct 1, 2026
Completion
Oct 15, 2026
Last update
Oct 20, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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