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Completed

NCT Number: NCT06561477

Role of ICCO Score in Predicting Outcome in ICU Patients

This study aims at calculating a specific score to cirrhotic patients admitted at ICU (ICCO score) and use this score to predict mortality and outcome for admitted patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university hospitals

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive care cirrhosis outcome (ICCO) score

Other

ICCO score will be calculated for the participants to use it as a predictor for mortality and ICU outcome The ICCO score is 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))

Primary outcomes

  1. Testing the validity of ICCO score in predicting mortality in critically ill patients with cirrhosis admitted to the ICU.

    Time frame: baseline

    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

Secondary outcomes

  1. Compare ICCO score with other established ICU scoring systems regarding their ability to predict mortality in ICU cirrhotic patients.

    Time frame: baseline

    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.

  2. Evaluate the utility of ICCO score in guiding clinical decision-making and resource allocation in ICU settings.

    Time frame: baseline

    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.

  3. Assess the correlation of ICCO score with severity of liver disease and other organ dysfunctions.

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Study of the Validity of Intensive Care Cirrhosis Outcome Score (ICCO) in Predicting Outcome in Cirrhotic Patients Admitted to Intensive Care Unit.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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