- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06561477
Role of ICCO Score in Predicting Outcome in ICU Patients
Study of the Validity of Intensive Care Cirrhosis Outcome Score (ICCO) in Predicting Outcome in Cirrhotic Patients Admitted to Intensive Care Unit.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Liver cirrhosis is the final stage of chronic liver disease. It is characterized by an irreversible replacement of liver parenchyma with fibrotic tissue and regenerative nodules. The major causes of cirrhosis include hepatitis B virus and hepatitis C virus infection, alcohol-associated liver disease (ALD), and non-alcoholic fatty liver disease (NAFLD).
The prognosis of cirrhotic patients admitted to the ICU remains poor It was reported that the mortality rate of patients with cirrhosis admitted to an intensive care unit (ICU) due to organ dysfunction ranges from 34% to 69% depending on the cause of admission, the presence of organ failure (OF) and the severity of the underlying liver disease.
Several prognostic scoring systems have been used to assess patients with cirrhosis admitted to the ICU, general ICU mortality risk scores; such as the Sequential Organ Failure Assessment (SOFA) score and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score, other liver specific scores such as Model of end stage liver disease (MELD) score.
These scores can be calculated immediately upon admission to the ICU (first 24 h) or during the first days of hospitalization, leading to an evolutionary assessment over this short period of time.
Intensive care cirrhotic outcome (ICCO) score is a new score that was introduced to predict mortality and ICU outcome in cirrhotic patients admitted to the ICU. with limited studies that test the validity of the score and compare it with the other well-known ICU scores.
In clinical practice, it remains controversial to determine which score is better at predicting overall mortality, this is due to that Each score is calculated according to its own criteria, and only data obtained within the first 24 hours of the first ICU admittance is used.
In this study investigators will test the validity of ICCO score and compare it with other different ICU scores to find out the most useful score in early prediction of ICU outcome for cirrhotic patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Asyut, Egypt
- Assiut University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (age ≥18 years) with cirrhosis admitted to the ICU.
- Confirmed diagnosis of cirrhosis based on clinical, radiological, and/or histological criteria.
- Need for intensive care management due to acute illness or complications related to cirrhosis.
Exclusion Criteria:
- Patients without a confirmed diagnosis of cirrhosis.
- Patients with acute liver failure not meeting criteria for cirrhosis.
- Patients with incomplete data for calculating ICCO.
- Patients transferred from another ICU.
- Patients who refuse participation in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Testing the validity of ICCO score in predicting mortality in critically ill patients with cirrhosis admitted to the ICU.
Time Frame: baseline
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ICCO score will be calculated to all participants based on the formula The ICCO score was 0.3707 + (0.0773 x bilirubin (mg/dl)) - (0.00849 x cholesterol (mg/dl)) -(0.0155 x creatinine clearance (ml/min)) + (0.1351 x lactate (mmol/l)).
and then correlation between ICCO score and ICU mortality will be tested
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compare ICCO score with other established ICU scoring systems regarding their ability to predict mortality in ICU cirrhotic patients.
Time Frame: baseline
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each score of these scores will be calculated to all patients at time of ICU admission, follow up will be done until end of ICU stay, then statistical analysis will be done to compare the effectiveness of each score in prediction of mortality.
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baseline
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Evaluate the utility of ICCO score in guiding clinical decision-making and resource allocation in ICU settings.
Time Frame: baseline
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after statistical analysis of collected data, if the ICCO score has good predictive value, then it can be used to make clinical decision for admission of patients to ICU or not depending of the prediction of their outcomes using the ICCO score.
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baseline
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Assess the correlation of ICCO score with severity of liver disease and other organ dysfunctions.
Time Frame: baseline
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ICCO score value will be calculated to all participants and statistical analysis will be done to find any correlation between ICCO score and degree of severity of liver disease.
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Huang DQ, Terrault NA, Tacke F, Gluud LL, Arrese M, Bugianesi E, Loomba R. Global epidemiology of cirrhosis - aetiology, trends and predictions. Nat Rev Gastroenterol Hepatol. 2023 Jun;20(6):388-398. doi: 10.1038/s41575-023-00759-2. Epub 2023 Mar 28.
- Zauner C, Schneeweiss B, Schneider B, Madl C, Klos H, Kranz A, Ratheiser K, Kramer L, Lenz K. Short-term prognosis in critically ill patients with liver cirrhosis: an evaluation of a new scoring system. Eur J Gastroenterol Hepatol. 2000 May;12(5):517-22. doi: 10.1097/00042737-200012050-00007.
- Gumilas NSA, Widodo I, Ratnasari N, Heriyanto DS. Potential relative quantities of miR-122 and miR-150 to differentiate hepatocellular carcinoma from liver cirrhosis. Noncoding RNA Res. 2022 Feb 6;7(1):34-39. doi: 10.1016/j.ncrna.2022.01.004. eCollection 2022 Mar.
- Abdellatif Z, Eletreby R, Samir R, Abdallah M, Lithy R, Zayed N. Outcome and prognostic markers of cirrhotic and non-cirrhotic patients admitted to a hepatology ICU in a tertiary care university hospital. Afr Health Sci. 2022 Jun;22(2):377-383. doi: 10.4314/ahs.v22i2.43.
- da Silveira F, Soares PHR, Marchesan LQ, da Fonseca RSA, Nedel WL. Assessing the prognosis of cirrhotic patients in the intensive care unit: What we know and what we need to know better. World J Hepatol. 2021 Oct 27;13(10):1341-1350. doi: 10.4254/wjh.v13.i10.1341.
- Elzouki AN, Suliman S, Alhasan R, Abdullah A, Othman M, Badi A. Predicting mortality of patients with cirrhosis admitted to medical intensive care unit: An experience of a single tertiary center. Arab J Gastroenterol. 2016 Dec;17(4):159-163. doi: 10.1016/j.ajg.2016.11.003. Epub 2016 Dec 15.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICCO score
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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