Capillary Leak Index as a Prognostic Indicator for Post-Operative Abdominal Sepsis in Critically Ill Patients (CLI)

December 6, 2025 updated by: Osama Khalil, Ain Shams University
In this study the investigators going to evaluate the "CLI" as an early prognostic indicator for post-operative abdominal sepsis in critically ill patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sepsis has been recognized as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for continuous research.

Peritonitis can be classified by the anatomical integrity of the abdominal cavity. Primary peritonitis is associated with undamaged intra-abdominal cavity organs. It is also known as spontaneous bacterial peritonitis and is treated without surgical intervention. The source of infection is often hard to establish and is usually found occurring in infants and cirrhotic patients.

Secondary peritonitis is an infection of the peritoneal cavity after hollow viscus perforation, anastomotic leak, ischemic necrosis, or other injuries of the gastrointestinal tract. Tertiary peritonitis is defined as a serious recurrent or persistent intra-abdominal infection after the successful control of secondary peritonitis. Irrespective of the cause, several measures are available and accepted as improving the survival rate, the most important being the early recognition of intra-abdominal infection. Efforts to achieve fluid balance should be initiated immediately to replace any intravascular insufficiency. Vasoactive agents may be necessary to augment and assist fluid restoration.

The treatment strategy for peritonitis primarily aims at the stabilization of possible organ dysfunction by routine intensive care medicine. Low risk secondary peritonitis (localized peritonitis), Ampicillin/Sulbactam or Carbapenem can be used as a monotherapy, however in combination therapy 2nd generation Cephalosporin + Metronidazole or 3rd generation Cephalosporin + Metronidazole can be used. High risk Secondary peritonitis Piperacillin/Tazobactam or Carbapenem or Tigecycline can be used as a monotherapy. A combination therapy 4th generation Cephalosporin + Metronidazole are usually used. Tertiary peritonitis antifungal therapy in high-risk patients and empirical therapy should cover the probable micro flora and should be changed according to the culture results.

Capillary leak syndrome (CLS) refers to a syndrome of deranged fluid homeostasis, often observed in critically ill patients, CLS is frequently defined by excessive fluid shift from the intravascular to the extravascular space, resulting in intravascular hypovolemia, extravascular edema formation, and hypo perfusion necessitating further fluid resuscitation. In health, fluid exchange between intravascular and extravascular spaces is vital for maintaining the body's homeostasis. However, disturbances in this delicate equilibrium, can lead to the clinical picture of CLS.

CLI is measured by dividing CRP level by albumin level. Systematic response to tissue injury, including major surgery, is marked by increased pro inflammatory cytokines, which promotes CRP production and capillary leakage. If the injury still exists, inflammatory process will continue.

Our study will be done to evaluate the association between capillary leak index (CLI) and intensive care unit (ICU) related mortality in patients underwent major abdominal surgery.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 7154411
        • Surgical intensive Care Unit, Ain Shams University Hospitals.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

ICU Patient Post operative abdominal sepesis

Description

Inclusion Criteria:

  • Age: ≥18 years old presented with Post-operative intra-abdominal sepsis due to secondary peritonitis.
  • Sex: Both sexes.
  • Post-Operative secondary peritonitis eg. Perforated viscus and abdominal abscess.
  • Estimated length of ICU stays ≥48 hrs.

Exclusion Criteria:

  • Patient refusal.
  • Advanced Liver diseases According New MELD score ≥ 20 )Kamath et al.,2001)
  • Renal diseases (Moderate decrease in GFR 30-59 ml/min/1.73m²--Severe decrease in GFR 15-29 ml/min/1.73m²--Kidney failure less than 15 ml/min/1.73m² or on Hemodialysis).
  • Pregnancy.
  • Primary peritonitis.
  • Tertiary peritonitis.
  • Mortality within first 48hrs of ICU admission.
  • Advanced malignancy ( Stage III localized malignancy with spreading lymph nodes Stage IV spreading to Other parts of the body such as to the liver, lungs and bones).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
low Capillary Leak Index < cutoff point 85.55
patient with Post operative Intra-abdominal sepsis with CLI at or less than 85.55 the cutoff point.
high Capillary Leak Index > cutoff point 85.55
patient with Post operative Intra-abdominal sepsis with CLI higher than 85.55 the cutoff point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Died by Day 28
Time Frame: 28 days after ICU admission
Baseline CLI will be calculated on ICU admission . Mortality status (alive or dead) will be assessed at 28 days after ICU admission. The primary outcome is the number of participants who died from any cause by day 28 after ICU admission. The Association between basline CLI and 28-day all- cause mortality will be evaluated.
28 days after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Stay [Unit: More Than 3 Days].
Time Frame: up to 28 days
ICU Stay [Unit: more than 3 Days].
up to 28 days
Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days]
Time Frame: up to 3 days

The Relationship Between Variables:

The investigators will analyze CLI as a prognostic indicator using logistic regression to predict risk of ICU mortality.
up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Ahmed M Ahmed, MD., Ain Shams University Faculty of Medicine
  • Study Chair: Hanaa A El-Gendy, MD, Ain Shams University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 10, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 6, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLI In Abdominal sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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