Liver CirrhosisNCT06561477
Role of ICCO Score in Predicting Outcome in ICU Patients
An observational study of Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Intensive care cirrhosis outcome (ICCO) score
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 6 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with confirmed diagnosis with liver cirrhosis admitted to the intensive care unit
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Validity of Intensive Care Cirrhosis Outcome Score (ICCO) in Predicting Outcome in Cirrhotic Patients Admitted to Intensive Care Unit.
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Intensive care cirrhosis outcome (ICCO) score
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive care cirrhosis outcome (ICCO) scoreOther
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))
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (3)
Compare ICCO score with other established ICU scoring systems regarding their ability to predict mortality in ICU cirrhotic patients.
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.
Measured: baseline
Evaluate the utility of ICCO score in guiding clinical decision-making and resource allocation in ICU settings.
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.
Measured: baseline
Assess the correlation of ICCO score with severity of liver disease and other organ dysfunctions.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Mar 2025
- Primary completion2 Jan 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mamdouh Nathan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561477
- Sponsor's protocol ID
- ICCO score
- Status last verified
- Feb 2026
- First submitted
- 9 Aug 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10833094Gumilas 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.
PubMed 35224317Huang 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.
PubMed 36977794Abdellatif 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.
PubMed 36407342da 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.
PubMed 34786170Elzouki 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.
PubMed 27988236
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Validity of Intensive Care Cirrhosis Outcome Score (ICCO) in Predicting Outcome in Cirrhotic Patients Admitted to Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT06561477
- Acronym / sponsor ID
- ICCO score
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with confirmed diagnosis with liver cirrhosis admitted to the intensive care unit
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive care cirrhosis outcome (ICCO) scoreICCO 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)) | Other | – |
Primary outcome
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
3 secondary outcomes
Compare ICCO score with other established ICU scoring systems regarding their ability to predict mortality in ICU cirrhotic patients.
Time frame: baseline
Evaluate the utility of ICCO score in guiding clinical decision-making and resource allocation in ICU settings.
Time frame: baseline
Assess the correlation of ICCO score with severity of liver disease and other organ dysfunctions.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 10833094Zauner 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.
- Background: PubMed 35224317Gumilas 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.
- Background: PubMed 36977794Huang 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.
- Background: PubMed 36407342Abdellatif 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.
- Background: PubMed 34786170da 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.
- Background: PubMed 27988236Elzouki 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing the validity of ICCO score in predicting mortality in critically ill patients with cirrhosis admitted to the ICU. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561477, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.