NCT06561477

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

August 9, 2024

Last Update Submit

February 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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

    baseline

Secondary Outcomes (3)

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

    baseline

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

    baseline

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

    baseline

Interventions

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))

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with confirmed diagnosis with liver cirrhosis admitted to the intensive care unit

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 10833094BACKGROUND
  • 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.

    PMID: 35224317BACKGROUND
  • 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.

    PMID: 36977794BACKGROUND
  • 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.

    PMID: 36407342BACKGROUND
  • 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.

    PMID: 34786170BACKGROUND
  • 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.

    PMID: 27988236BACKGROUND

Related Links

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 20, 2024

Study Start

March 1, 2025

Primary Completion

January 2, 2026

Study Completion

February 6, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations