An observational study in Intra-Abdominal Infections, Intestinal Obstruction and Appendicitis Acute, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Ain Shams University · Observational
In this study the investigators going to evaluate the "CLI" as an early prognostic indicator for post-operative abdominal sepsis in critically ill patients.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 151 observational studies indexed under Appendicitis.
Browse Appendicitis studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Appendicitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Intraabdominal Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
ICU Patient Post operative abdominal sepesis
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.
Exclusion Criteria:
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patient with Post operative Intra-abdominal sepsis with CLI at or less than 85.55 the cutoff point.
patient with Post operative Intra-abdominal sepsis with CLI higher than 85.55 the cutoff point.
Number of Participants Who Died by Day 28
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.
Time frame: 28 days after ICU admission
ICU Stay [Unit: More Than 3 Days].
ICU Stay \[Unit: more than 3 Days\].
Time frame: up to 28 days
Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days]
The Relationship Between Variables: The investigators will analyze CLI as a prognostic indicator using logistic regression to predict risk of ICU mortality.
Time frame: up to 3 days
"100 Participants were recruited from Surgical intensive Care Unit, Ain Shams University Hospitals. In between March 2025 and Aug 2025." "Recruitment was conducted through ICU."
| Milestone | Low CLI at or Less Than Cutoff Point 85.55 | High CLI More Than Cutoff Point 85.55 |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
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.
| Participants | Low CLI equal or less than 85.55 cutoff point. | High CLI greater than 85.55 cutoff point. |
|---|---|---|
| Number of Participants Who Died by Day 28 | 8 (3 to 20) | 23 (2 to 16) |
ICU Stay \[Unit: more than 3 Days\].
| days | Low CLI equal or less than 85.55 cutoff point. | High CLI greater than 85.55 cutoff point. |
|---|---|---|
| ICU Stay [Unit: More Than 3 Days]. | 7.96 (5 to 10) | 8.78 (7 to 12) |
The Relationship Between Variables: The investigators will analyze CLI as a prognostic indicator using logistic regression to predict risk of ICU mortality.
| ng/ml | Low CLI equal or less than 85.55 cutoff point. | High CLI greater than 85.55 cutoff point. |
|---|---|---|
| Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days] | 8.65 ± 16.55 | 16.62 ± 20.63 |
Collected over from the second day of ICU admission until end of follow-up, up to 28 days.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low CLI Equal or Less Than 85.55 Cutoff Point. | 8/50 (16%) | 27/50 (54%) | 14/50 (28%) |
| High CLI Greater Than 85.55 Cutoff Point. | 23/50 (46%) | 35/50 (70%) | 19/50 (38%) |
| Event | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. |
|---|---|---|
| Acute Kidney injury (AKI)Renal and urinary disorders | 15/50 | 17/50 |
| Acute Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders | 7/50 | 12/50 |
| Multi Organ DisfunctionsGeneral disorders | 4/50 | 6/50 |
| Disseminated intravascular coagulation (DIC)Blood and lymphatic system disorders | 1/50 | 0/50 |
| Event | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. |
|---|---|---|
| feverImmune system disorders | 6/50 | 10/50 |
| VomitingGastrointestinal disorders | 6/50 | 7/50 |
| constipationGastrointestinal disorders | 2/50 | 2/50 |
| Age, Customized(Age (years)) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| Age | 56 (18 to 88) | 60 (19 to 89) | 58 (18 to 89) |
| Sex: Female, Male(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| Female | 13 | 12 | 25 |
| Male | 37 | 38 | 75 |
| Diabetes mellitus disease (DM)(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| positive | 14 | 18 | 32 |
| negative | 36 | 32 | 68 |
| Cardiovascular diseases(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| positive | 19 | 17 | 36 |
| negative | 31 | 33 | 64 |
| Hepatic diseases(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| Positive | 1 | 2 | 3 |
| Negative | 49 | 48 | 97 |
| Renal diseases(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| positive | 6 | 9 | 15 |
| negative | 44 | 41 | 85 |
| surgical history(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| positive | 22 | 16 | 38 |
| negative | 28 | 34 | 62 |
| Drugs History(Participants) | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| positive | 27 | 24 | 51 |
| negative | 23 | 26 | 49 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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