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

NCT06901544 | Completed Results

• 1 other identifier: CLI In Abdominal sepsis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators going to evaluate the "CLI" as an early prognostic indicator for post-operative abdominal sepsis in critically ill patients.

Conditions

Intra-Abdominal Infections; Intestinal Obstruction; Appendicitis Acute; Perforated Viscus

Keywords

Capillary Leak Index; secondary abdominal sepsis; sepsis; Prognostic value; Good indicator; mortality; Intensive Care Unit; ICU

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• ICU Stay [Unit: More Than 3 Days].

  up to 28 days

• Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days]

  up to 3 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU Patient Post operative abdominal sepesis

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Surgical intensive Care Unit, Ain Shams University Hospitals.

Cairo, Cairo Governorate, 7154411, Egypt

Location

Related Publications (13)

• 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.

  PMID: 24171518 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).

  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.

  PMID: 26677396 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.

  PMID: 38117435 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.

  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.

  PMID: 36186801 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.

  PMID: 30574564 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.

  PMID: 24287460 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.

  PMID: 25887649 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.

  PMID: 11172350 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.

  PMID: 28268067 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.

  PMID: 33406974 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.

  RESULT

MeSH Terms

Conditions

Intraabdominal Infections; Intestinal Obstruction; Appendicitis; Sepsis

Condition Hierarchy (Ancestors)

Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Cecal Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Osama Khalil
• Organization: Ain Shams University, Faculty of Medicine

Osama.Ahmed.Ahmed.Salem.Khalil@med.asu.edu.eg

01010000903

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 30, 2025
• Study Start: March 4, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 10, 2025
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-09

Locations

EG (1)