AKI in CirrhosisNCT07797114
Predictors of Mortality in Cirrhotic Patients With Acute Kidney Injury
An observational study of AKI in Cirrhosis, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AKI in Cirrhosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2027
- How long will I take part?
- 1 Year
- 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: This study targets adult patients diagnosed with liver cirrhosis who develop acute kidney injury (AKI) during their admission or evaluation at the gastroenterology and hepatology departments or intensive care units. Diagnosis of liver cirrhosis is established based on clinical, laboratory, and ultrasonographic findings. Acute kidney injury is defined and staged according to the International Club of Ascites (ICA-AKI) or KDIGO criteria. The population reflects real-world clinical presentations of decompensated cirrhotic patients requiring urgent medical evaluation for renal impairment.
Who may be able to join
- Adults aged ≥ 18 years.
- Hospitalized cirrhotic patients who develop AKI and mortality occurs within 30 days of the development of AKI
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read the 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.
- Conditions
- AKI in Cirrhosis
- Keywords
- AKI, Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term mortality
Mortality among cirrhotic patients presenting with acute kidney injury
Measured: From hospital admission up to hospital discharge, an average of 2 weeks
Secondary outcomes (1)
Serum creatinine associated with in-hospital mortality
Serum creatinine will be assessed at hospital admission and its association with in-hospital mortality will be evaluated.
Measured: From hospital admission up to hospital discharge, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI in 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Emad el-din Salah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797114
- Sponsor's protocol ID
- AKI in cirrhotic patients
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Predictors of Short-Term Mortality in Cirrhotic Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07797114
- Acronym / sponsor ID
- AKI in cirrhotic patients
- Conditions
- AKI in Cirrhosis
- Keywords
- AKI, Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Sep 2026 (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.
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 .
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic Patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study targets adult patients diagnosed with liver cirrhosis who develop acute kidney injury (AKI) during their admission or evaluation at the gastroenterology and hepatology departments or intensive care units. Diagnosis of liver cirrhosis is established based on clinical, laboratory, and ultrasonographic findings. Acute kidney injury is defined and staged according to the International Club of Ascites (ICA-AKI) or KDIGO criteria. The population reflects real-world clinical presentations of decompensated cirrhotic patients requiring urgent medical evaluation for renal impairment.
Key inclusion criteria (2 listed)
- Adults aged ≥ 18 years.
- Hospitalized cirrhotic patients who develop AKI and mortality occurs within 30 days of the development of AKI
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Serum creatinine associated with in-hospital mortality
Time frame: From hospital admission up to hospital discharge, an average of 2 weeks
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 1 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI in Cirrhosis, run by Assiut University.
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 2 inclusion and 6 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 emad salah, MBBCh (+201005127591, muhamed.emad19@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term mortality (time frame: From hospital admission up to hospital discharge, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.