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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Stay [Unit: More Than 3 Days]. | ICU Stay [Unit: more than 3 Days]. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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ICU Patient Post operative abdominal sepesis
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Ahmed, MD. | Ain shams University Faculty of medicine | Study Director |
| Hanaa A El-Gendy, MD | Ain Shams University Faculty of medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical intensive Care Unit, Ain Shams University Hospitals. | Cairo | Cairo Governorate | 7154411 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24171518 | Result | Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available. | |
| Result | 12. Susanti A, Lestari MI, Sedono R, IA L. High capillary leak index is associated with increased risk of ICU-related mortality after major abdominal surgery. Critical Care & Shock. 2021 Nov 1;24(6). | ||
| 26677396 |
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the 100 participants enrolled.
"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."
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| ID | Title | Description |
|---|---|---|
| FG000 | Low CLI at or Less Than Cutoff Point 85.55 | 50 Participants patient with Post operative Intra-abdominal sepsis with CLI at or less than 85.55 the cutoff point. This group included 100 adult ICU patients with post-operative secondary intra-abdominal sepsis. The Capillary Leak Index (CLI) was calculated for each participant using the formula: (CRP ÷ Albumin) × 100. Patients were stratified into low and high CLI subgroups according to the cutoff Point of 85.55 for prognostic analysis. |
| FG001 | High CLI More Than Cutoff Point 85.55 | 50 Participants patient with Post operative Intra-abdominal sepsis with High CLI more than 85.55 the cutoff point. This group included 100 adult ICU patients with post-operative secondary intra-abdominal sepsis. The Capillary Leak Index (CLI) was calculated for each participant using the formula: (CRP ÷ Albumin) × 100. Patients were stratified into low and high CLI subgroups according to the cutoff Point of 85.55 for prognostic analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low CLI Equal or Less Than 85.55 Cutoff Point. | Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality. |
| BG001 | High CLI Greater Than 85.55 Cutoff Point. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 28 days after ICU admission |
|
from the second day of ICU admission until end of follow-up, up to 28 days.
"Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low CLI Equal or Less Than 85.55 Cutoff Point. | Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation (DIC) | Blood and lymphatic system disorders | MedDRA10.0 | Systematic Assessment | DIC occurs in severe form of sepsis complications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
In this study, 124 patients were assessed for eligibility, 18 patients did not meet the criteria and 6 patients refused to participate in the study. The remaining patients were randomly allocated into two equal groups (50 patients in each). All allocated patients were followed-up and analyzed statistically.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Osama Khalil | Ain Shams University, Faculty of Medicine | 01010000903 | Osama.Ahmed.Ahmed.Salem.Khalil@med.asu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: plan of study | Aug 11, 2025 | Aug 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007415 | Intestinal Obstruction |
| D001064 | Appendicitis |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| up to 3 days |
| Result |
| Sartelli M, Abu-Zidan FM, Catena F, Griffiths EA, Di Saverio S, Coimbra R, Ordonez CA, Leppaniemi A, Fraga GP, Coccolini F, Agresta F, Abbas A, Abdel Kader S, Agboola J, Amhed A, Ajibade A, Akkucuk S, Alharthi B, Anyfantakis D, Augustin G, Baiocchi G, Bala M, Baraket O, Bayrak S, Bellanova G, Beltran MA, Bini R, Boal M, Borodach AV, Bouliaris K, Branger F, Brunelli D, Catani M, Che Jusoh A, Chichom-Mefire A, Cocorullo G, Colak E, Costa D, Costa S, Cui Y, Curca GL, Curry T, Das K, Delibegovic S, Demetrashvili Z, Di Carlo I, Drozdova N, El Zalabany T, Enani MA, Faro M, Gachabayov M, Gimenez Maurel T, Gkiokas G, Gomes CA, Gonsaga RA, Guercioni G, Guner A, Gupta S, Gutierrez S, Hutan M, Ioannidis O, Isik A, Izawa Y, Jain SA, Jokubauskas M, Karamarkovic A, Kauhanen S, Kaushik R, Kenig J, Khokha V, Kim JI, Kong V, Koshy R, Krasniqi A, Kshirsagar A, Kuliesius Z, Lasithiotakis K, Leao P, Lee JG, Leon M, Lizarazu Perez A, Lohsiriwat V, Lopez-Tomassetti Fernandez E, Lostoridis E, Mn R, Major P, Marinis A, Marrelli D, Martinez-Perez A, Marwah S, McFarlane M, Melo RB, Mesina C, Michalopoulos N, Moldovanu R, Mouaqit O, Munyika A, Negoi I, Nikolopoulos I, Nita GE, Olaoye I, Omari A, Ossa PR, Ozkan Z, Padmakumar R, Pata F, Pereira Junior GA, Pereira J, Pintar T, Pouggouras K, Prabhu V, Rausei S, Rems M, Rios-Cruz D, Sakakushev B, Sanchez de Molina ML, Seretis C, Shelat V, Simoes RL, Sinibaldi G, Skrovina M, Smirnov D, Spyropoulos C, Tepp J, Tezcaner T, Tolonen M, Torba M, Ulrych J, Uzunoglu MY, van Dellen D, van Ramshorst GH, Vasquez G, Venara A, Vereczkei A, Vettoretto N, Vlad N, Yadav SK, Yilmaz TU, Yuan KC, Zachariah SK, Zida M, Zilinskas J, Ansaloni L. Global validation of the WSES Sepsis Severity Score for patients with complicated intra-abdominal infections: a prospective multicentre study (WISS Study). World J Emerg Surg. 2015 Dec 16;10:61. doi: 10.1186/s13017-015-0055-0. eCollection 2015. |
| 38117435 | Result | Saravi B, Goebel U, Hassenzahl LO, Jung C, David S, Feldheiser A, Stopfkuchen-Evans M, Wollborn J. Capillary leak and endothelial permeability in critically ill patients: a current overview. Intensive Care Med Exp. 2023 Dec 20;11(1):96. doi: 10.1186/s40635-023-00582-8. |
| Result | 9. PALACIOS MOGUEL, Paul et al. Capillary leak index as a new prognostic tool in septic shock Med. Crít. (Col. Mex. Med. Crít.) vol.32 no.3 Mexico City May/Jun. 2018. |
| 36186801 | Result | Meng R, Guan X, Sun L, Fei Z, Li Y, Luo M, Ma A, Li H. The efficacy and safety of eravacycline compared with current clinically common antibiotics in the treatment of adults with complicated intra-abdominal infections: A Bayesian network meta-analysis. Front Med (Lausanne). 2022 Sep 16;9:935343. doi: 10.3389/fmed.2022.935343. eCollection 2022. |
| 30574564 | Result | Muresan MG, Balmos IA, Badea I, Santini A. Abdominal Sepsis: An Update. J Crit Care Med (Targu Mures). 2018 Oct 1;4(4):120-125. doi: 10.2478/jccm-2018-0023. eCollection 2018 Oct. |
| 24287460 | Result | Morrissey I, Hackel M, Badal R, Bouchillon S, Hawser S, Biedenbach D. A Review of Ten Years of the Study for Monitoring Antimicrobial Resistance Trends (SMART) from 2002 to 2011. Pharmaceuticals (Basel). 2013 Nov 1;6(11):1335-46. doi: 10.3390/ph6111335. |
| 25887649 | Result | Montravers P, Dufour G, Guglielminotti J, Desmard M, Muller C, Houissa H, Allou N, Marmuse JP, Augustin P. Dynamic changes of microbial flora and therapeutic consequences in persistent peritonitis. Crit Care. 2015 Mar 2;19(1):70. doi: 10.1186/s13054-015-0789-9. |
| 11172350 | Result | Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172. |
| 28268067 | Result | Donnelly JP, Safford MM, Shapiro NI, Baddley JW, Wang HE. Application of the Third International Consensus Definitions for Sepsis (Sepsis-3) Classification: a retrospective population-based cohort study. Lancet Infect Dis. 2017 Jun;17(6):661-670. doi: 10.1016/S1473-3099(17)30117-2. Epub 2017 Mar 4. |
| 33406974 | Result | Clements TW, Tolonen M, Ball CG, Kirkpatrick AW. Secondary Peritonitis and Intra-Abdominal Sepsis: An Increasingly Global Disease in Search of Better Systemic Therapies. Scand J Surg. 2021 Jun;110(2):139-149. doi: 10.1177/1457496920984078. Epub 2021 Jan 7. |
| Result | 1. Ade Susanti1,2 , Mayang Indah Lestari et al. High capillary leak index is associated with increased risk of ICU-related mortality after major abdominal surgery Crit Care Shock 2021) 24:293-300. |
Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality. |
| BG002 | Total | Total of all reporting groups |
| Age (years) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diabetes mellitus disease (DM) | patients with or without past medical history with Diabetes mellitus (DM) | Count of Participants | Participants |
|
| Cardiovascular diseases | patients with or without Cardiovascular diseases | Count of Participants | Participants |
|
| Hepatic diseases | according New MELD Score less than 20 | Count of Participants | Participants |
|
| Renal diseases | Mild GFR decrease (GFR > 60) | Count of Participants | Participants |
|
| surgical history | history of surgical major operation | Count of Participants | Participants |
|
| Drugs History | patient on regular medical Drugs intake for chronic diseases | Count of Participants | Participants |
|
| Acute Physiology and Chronic Health Evaluation (APACHE II),Sequential Organ Failure Assessment(SOFA) |
| Median | Inter-Quartile Range | Score on a Scale |
|
| Abdominal Pain | Mean | Standard Deviation | days |
|
| GIT symptoms | Count of Participants | Participants |
|
| Kidney function tests | laboratory investigation | Mean | Full Range | mg/dL |
|
| C Reactive Protein (CRP) | Mean | Full Range | mg/dL |
|
| Fever | Count of Participants | Participants |
|
| Albumin | Mean | Full Range | g/L |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | (kg/m2) |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality. |
|
|
|
| Secondary | ICU Stay [Unit: More Than 3 Days]. | ICU Stay [Unit: more than 3 Days]. | Posted | Mean | Inter-Quartile Range | days | up to 28 days |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | up to 3 days |
|
|
|
|
| 8 |
| 50 |
| 27 |
| 50 |
| 14 |
| 50 |
| EG001 | High CLI Greater Than 85.55 Cutoff Point. | Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality. | 23 | 50 | 35 | 50 | 19 | 50 |
|
| Acute Kidney injury (AKI) | Renal and urinary disorders | MedDRA10.0 | Systematic Assessment |
|
| Multi Organ Disfunctions | General disorders | MedDRA10.0 | Systematic Assessment |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
|
| fever | Immune system disorders | MedDRA10.0 | Systematic Assessment |
|
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| D005759 |
| Gastroenteritis |
| D002429 | Cecal Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |