NCT06924294

Brief Summary

  • To characterize the pattern and the prevalence of renal affection among liver cirrhosis patients.
  • To evaluate the short-term outcomes of those patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 24, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 24, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

renal affection in patients with liver cirrhosis

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality

    Mortality during hospital stay

    Through the study completion , average 6 months

  • Phenotypes of acute kidney injury across geographic areas

    Characteristics of acute kidney injury (clinical type and stage)

    Baseline ( at admission ), then through the study completion, average 6 months

Secondary Outcomes (3)

  • 28-day mortality

    28 days

  • Resolution of AKI

    Hospital stay (up to 90 days)

  • Development of CKD

    90 days

Study Arms (1)

liver cirrhosis admitted to Al-Rajhi liver hospital

observation of renal affection in patients known to have liver cirrhosis

Other: observation of renal affection in patients with liver cirrhosis

Interventions

* CBC * Liver function test * kidney function test (serum creatinine, BUN, eGFR (EPI equation and MDRD equation) , * Prothrombin time and concentration, INR, * Serum electrolytes * Urine analysis.

liver cirrhosis admitted to Al-Rajhi liver hospital

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with liver cirrhosis admitted to the department .

You may qualify if:

  • Patients with liver cirrhosis admitted to the department .

You may not qualify if:

  • Patients with known preexisting chronic kidney disease according to KDIGO and EASL 2018 definitions ( defined as functional GFR \<60 ml/min per 1.73 m 2 for ≥3 months or structural kidney damage for ≥3 months ).
  • Patient refusal to give informed consent ( or his first degree relatives in case of disturbed conscious level).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Raghi liver hospital

Asyut, Assuit, Egypt

Location

Related Publications (2)

  • Choi YJ, Kim JH, Koo JK, Lee CI, Lee JY, Yang JH, Ko SY, Choe WH, Kwon SY, Lee CH. Prevalence of renal dysfunction in patients with cirrhosis according to ADQI-IAC working party proposal. Clin Mol Hepatol. 2014 Jun;20(2):185-91. doi: 10.3350/cmh.2014.20.2.185. Epub 2014 Jun 30.

    PMID: 25032185BACKGROUND
  • Duah A, Nkrumah KN. Prevalence and predictors for spontaneous bacterial peritonitis in cirrhotic patients with ascites admitted at medical block in Korle-Bu Teaching Hospital, Ghana. Pan Afr Med J. 2019 May 16;33:35. doi: 10.11604/pamj.2019.33.35.18029. eCollection 2019.

    PMID: 31384350BACKGROUND

Related Links

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Omar Abd El-Malek, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohamed Omar Abd El-Malek, professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 11, 2025

Study Start

June 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations