Liver CirrhosisNCT06924294
Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital
An observational study of Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
Trial summary
To characterize the pattern and the prevalence of renal affection among liver cirrhosis patients. To evaluate the short-term outcomes of those patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- observation of renal affection in patients with liver cirrhosis
- How many people
- 290 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with liver cirrhosis admitted to the department .
Who may be able to join
- Patients with liver cirrhosis admitted to the department .
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Raghi liver hospital
Asyut, Assuit
Al-Rajhi liver hospital, 088208105, info@rlh-egy.com
About this study
- To characterize the pattern and the prevalence of renal affection among liver cirrhosis patients.
- To evaluate the short-term outcomes of those patients.
Read the 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 .
- Conditions
- Liver Cirrhosis
- Being tested
- observation of renal affection in patients with liver cirrhosis
- Keywords
- renal affection in patients with liver cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of renal affection in patients with liver cirrhosisOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| liver cirrhosis admitted to Al-Rajhi liver hospital | observation of renal affection in patients known to have liver cirrhosis Receives: Other: observation of renal affection in patients with liver cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Mortality during hospital stay
Measured: Through the study completion , average 6 months
Phenotypes of acute kidney injury across geographic areas
Characteristics of acute kidney injury (clinical type and stage)
Measured: Baseline ( at admission ), then through the study completion, average 6 months
Secondary outcomes (3)
28-day mortality
Mortality at 28 days
Measured: 28 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
Measured: Hospital stay (up to 90 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Radwan Riad, Assiut University
- Investigators
- Mohamed Omar Abd El-Malek, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924294
- Sponsor's protocol ID
- liver cirrhosis
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25032185Duah 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.
PubMed 31384350
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital
- ClinicalTrials.gov ID
- NCT06924294
- Acronym / sponsor ID
- liver cirrhosis
- Conditions
- Liver Cirrhosis
- Keywords
- renal affection in patients with liver cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To characterize the pattern and the prevalence of renal affection among liver cirrhosis patients.
- To evaluate the short-term outcomes of those patients.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver cirrhosis admitted to Al-Rajhi liver hospital | – | Other: observation of renal affection in patients with liver cirrhosisobservation of renal affection in patients known to have liver cirrhosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with liver cirrhosis admitted to the department .
Key inclusion criteria (1 listed)
- Patients with liver cirrhosis admitted to the department .
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | liver cirrhosis admitted to Al-Rajhi liver hospital |
Primary outcome
In-hospital mortality
Time frame: Through the study completion , average 6 months
Mortality during hospital stay
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)
3 secondary outcomes
28-day mortality
Time frame: 28 days
Resolution of AKI
Time frame: Hospital stay (up to 90 days)
Development of CKD
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 25032185Choi 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.
- Results publication: PubMed 31384350Duah 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.
- 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\&authorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Omar Abd El-Malek, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Omar Abd El-Malek, professor (0201007343214, Omar7619@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Through the study completion , average 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.