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Not yet recruitingNCT07797114Updated Sep 1, 2026

Predictors of Mortality in Cirrhotic Patients With Acute Kidney Injury

An observational study in AKI in Cirrhosis, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

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:

  1. To evaluate the clinical presentation and laboratory parameters of cirrhotic patients at the time of AKI diagnosis.
  2. To determine independent clinical and laboratory factors associated with short-term mortality.
  3. 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.

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Conditions studied

  • AKI in Cirrhosis

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Keywords

  • AKI
  • Cirrhosis
03

In context

Fibrosis

1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.

This study's planned enrollment of 100 is below the median of 157 across 386 observational studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged ≥ 18 years.
  • Hospitalized cirrhotic patients who develop AKI and mortality occurs within 30 days of the development of AKI

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients with 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Cirrhotic Patients
06

What researchers measure

Primary outcomes

  1. Short-term mortality

    Mortality among cirrhotic patients presenting with acute kidney injury

    Time frame: 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.

    Time frame: From hospital admission up to hospital discharge, an average of 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.

Of 177 non-industry observational studies under Fibrosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 105. This study's planned 0 months is below that.

Counting every sponsor, half of 186 studies reached it within 48 months; a quarter within 21 and three quarters within 105.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2026
First posted
Sep 1, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07797114
Lead sponsor
Assiut University
Responsible party
Mohamed Emad el-din Salah (Resident, Assiut University) — Principal investigator
First posted
Sep 1, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

mohamed emad salah, MBBCh
Contact
muhamed.emad19@icloud.com
+201005127591

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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