Peritonitis InfectiousNCT07232342
Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes
An observational study of Peritonitis Infectious, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis Infectious
- What is being tested?
- Capillary Leak Index Versus
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2025to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Peritonitis Infectious
- Being tested
- Capillary Leak Index Versus
- Keywords
- Peritonitis, Capillary Leak Index, Conventional Biomarkers, Critically Ill Patients
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary Leak Index VersusDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay o | Not described Receives: Diagnostic Test: Capillary Leak Index Versus |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: From 1-10-2025 to 1-10-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start10 Dec 2025
- Primary completion1 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritonitis InfectiousStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232342
- Sponsor's protocol ID
- BenhaU123456789
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes
- ClinicalTrials.gov ID
- NCT07232342
- Acronym / sponsor ID
- BenhaU123456789
- Conditions
- Peritonitis Infectious
- Keywords
- Peritonitis, Capillary Leak Index, Conventional Biomarkers, Critically Ill Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay o | – | Diagnostic Test: Capillary Leak Index Versus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- 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.
Key exclusion criteria (8 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary Leak Index VersusBlood 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 | Diagnostic test | adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay o |
Primary outcome
all-cause mortality
Time frame: From 1-10-2025 to 1-10-2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis Infectious, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: From 1-10-2025 to 1-10-2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.