Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital

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

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Other: observation of renal affection in patients with liver cirrhosis

Detailed Description

Liver cirrhosis is a chronic liver disease characterized by significant scarring and dysfunction. One of its common complications is renal affection , which can significantly impact patient outcomes .

Aetiology of AKI can be categorized into three main types. These are prerenal (results from decreased renal perfusion), intrinsic renal (acute tubular necrosis), and postrenal AKI. In patients on admission, acute tubular necrosis is a common type of intrinsic AKI .

The development of portal hypertension in patients with liver cirrhosis leading to a reduction in systemic vascular resistance as a result of primary arterial vasodilation in the splanchnic circulation is the primary cause of AKI in cirrhotics. This mechanism primarily leads to hepatorenal syndrome. In addition, the underlying causes of liver cirrhosis can be the cause of intrinsic renal disease .

Early identification and management of AKI may improve outcomes. AKI in patients with liver cirrhosis in Egypt and their impact on inpatient mortality are largely unknown. This study was aimed at determining the prevalence, precipitating factors, predictors, and in-hospital mortality of AKI in patients with liver cirrhosis admitted at Al-Rajhi liver hospital at Egypt .

• Study Type: Observational
• Enrollment (Estimated): 290

Contacts and Locations

• Study Contact: Name: Mohamed Omar Abd El-Malek, professor; Phone Number: 0201007343214; Email: Omar7619@aun.edu.eg

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt
      • Al-Raghi liver hospital
      • Contact: Al-Rajhi liver hospital; Phone Number: 088208105; Email: info@rlh-egy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with liver cirrhosis admitted to the department .

Description

Inclusion Criteria:

• Patients with liver cirrhosis admitted to the department .

Exclusion Criteria:

1. 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 ).
2. Patient refusal to give informed consent ( or his first degree relatives in case of disturbed conscious level).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Mortality at 28 days	28 days
Development of CKD	Chronic kidney disease will be defined as an estimated glomerular filtration rate <60 ml/min ml/min/1.73 m2 for >3 months. The Modification of Diet in Renal Disease equation will be used for estimating glomerular filtration rate	90 days
Resolution of AKI	Resolution of AKI will be defined as return of serum creatinine to a value within 0.3 mg/di (26.5 mmol/L) of the baseline value. Partial response will be defined as regression of AKI to a lower stage with a reduction of serum creatinine to ≥0.3 mg/d| (26.5 mmol/L) above the baseline value	Hospital stay (up to 90 days)

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed Omar Abd El-Malek, professor, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• https://scholar.google.com/scholar_lookup?journal=Clinical%20and%20Molecular%20Hepatology&title=Prevalence%20of%20renal%20dysfunction%20in%20patients%20with%20cirrhosis%20according%20to%20ADQI-IAC%20working%20party%20proposal&author=Y.%20J.%20Choi&author

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: renal affection in patients with liver cirrhosis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: liver cirrhosis

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
• product manufactured in and exported from the U.S.: No