Predictors of Mortality in Cirrhotic Patients With Acute Kidney Injury

August 30, 2026 updated by: Mohamed Emad el-din Salah, Assiut University

Clinical and Laboratory Predictors of Short-Term Mortality in Cirrhotic Patients With Acute Kidney Injury

Acute kidney injury (AKI) is a common and severe complication in patients with liver cirrhosis, significantly increasing the risk of short-term mortality. Early identification of clinical and laboratory predictors of mortality in these patients is crucial for risk stratification and optimizing clinical management.

This study aims to identify the key clinical parameters (such as the presence of ascites, hepatic encephalopathy, and hemodynamics) and laboratory markers (such as serum creatinine, bilirubin, albumin, sodium, and INR) that predict short-term mortality in cirrhotic patients presenting with AKI. The findings will assist clinicians in recognizing high-risk patients early and tailoring targeted therapeutic interventions .

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Cirrhosis-associated acute kidney injury (AKI) represents a major prognostic milestone in the clinical course of end-stage liver disease. While baseline scoring systems like the Model for End-Stage Liver Disease (MELD) and Child-Pugh score provide overall prognostic value, specific clinical and dynamic laboratory predictors are needed to refine short-term mortality risk assessment in the context of AKI.

Objectives:

  1. To evaluate the clinical presentation and laboratory parameters of cirrhotic patients at the time of AKI diagnosis.
  2. To determine independent clinical and laboratory factors associated with short-term mortality.
  3. To assess the predictive performance of clinical scoring systems in this specific cohort.

Methodology:

This observational study will enroll patients diagnosed with liver cirrhosis and AKI based on International Club of Ascites (ICA-AKI) criteria. Comprehensive clinical evaluations and laboratory investigations will be recorded at baseline/admission. Patients will be followed up for [30 / 90 days] to assess clinical outcomes, including survival, recovery of renal function, or mortality. Multivariate statistical analysis will be applied to identify independent mortality predictors.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study targets adult patients diagnosed with liver cirrhosis who develop acute kidney injury (AKI) during their admission or evaluation at the gastroenterology and hepatology departments or intensive care units. Diagnosis of liver cirrhosis is established based on clinical, laboratory, and ultrasonographic findings. Acute kidney injury is defined and staged according to the International Club of Ascites (ICA-AKI) or KDIGO criteria. The population reflects real-world clinical presentations of decompensated cirrhotic patients requiring urgent medical evaluation for renal impairment.

Description

Inclusion Criteria:

  • Adults aged ≥ 18 years.
  • Hospitalized cirrhotic patients who develop AKI and mortality occurs within 30 days of the development of AKI

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients with HIV infection.
  • Patients with previous liver transplantation.
  • Patients with incomplete clinical or laboratory data
  • Patients with end-stage chronic kidney disease on maintenance dialysis.
  • Patients with acute liver failure without underlying liver cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cirrhotic Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term mortality
Time Frame: From hospital admission up to hospital discharge, an average of 2 weeks
Mortality among cirrhotic patients presenting with acute kidney injury
From hospital admission up to hospital discharge, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum creatinine associated with in-hospital mortality
Time Frame: From hospital admission up to hospital discharge, an average of 2 weeks
Serum creatinine will be assessed at hospital admission and its association with in-hospital mortality will be evaluated.
From hospital admission up to hospital discharge, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 23, 2026

First Submitted That Met QC Criteria

August 30, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AKI in cirrhotic patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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