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NCT Number: NCT06924294

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with liver cirrhosis admitted to the department .

Exclusion criteria

  • 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).

Treatment and study plan

observation of renal affection in patients with liver cirrhosis

Other
  • 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.

Primary outcomes

  1. In-hospital mortality

    Time frame: Through the study completion , average 6 months

    Mortality during hospital stay

  2. Phenotypes of acute kidney injury across geographic areas

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

    Characteristics of acute kidney injury (clinical type and stage)

Secondary outcomes

  1. 28-day mortality

    Time frame: 28 days

    Mortality at 28 days

  2. Resolution of AKI

    Time frame: Hospital stay (up to 90 days)

    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

  3. Development of CKD

    Time frame: 90 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Omar Abd El-Malek, professor

CONTACT

[email protected]

0201007343214

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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