Capillary Leak Index as a Prognostic Indicator for Post-Operative Abdominal Sepsis in Critically Ill Patients
NCT ID: NCT06901544
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
100 participants
OBSERVATIONAL
2025-03-04
2025-08-10
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
high Capillary Leak Index > cutoff point 85.55
patient with Post operative Intra-abdominal sepsis with CLI higher than 85.55 the cutoff point.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Sex: Both sexes.
* Post-Operative secondary peritonitis eg. Perforated viscus and abdominal abscess.
* Estimated length of ICU stays ≥48 hrs.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Osama Khalil
Principal Investigator
Principal Investigators
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Ahmed M Ahmed, MD.
Role: STUDY_DIRECTOR
Ain shams University Faculty of medicine
Hanaa A El-Gendy, MD
Role: STUDY_CHAIR
Ain Shams University Faculty of medicine
Locations
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Surgical intensive Care Unit, Ain Shams University Hospitals.
Cairo, Cairo Governorate, Egypt
Countries
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References
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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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: plan of study
Other Identifiers
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CLI In Abdominal sepsis
Identifier Type: -
Identifier Source: org_study_id