- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07797114
Predictors of Mortality in Cirrhotic Patients With Acute Kidney Injury
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
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:
- To evaluate the clinical presentation and laboratory parameters of cirrhotic patients at the time of AKI diagnosis.
- To determine independent clinical and laboratory factors associated with short-term mortality.
- 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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: mohamed emad salah, MBBCh
- Phone Number: +201005127591
- Email: muhamed.emad19@icloud.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- AKI in cirrhotic patients
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
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