Acute Kidney Injury in Patients With Liver Cirrhosis | NCT06343389

Studies
Acute Kidney Injury in Patients With Liver Cirrhosis

NCT06343389

Sponsor

Sohag University

Status

Completed

Last Update Posted

Apr 15, 2026Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Acute Kidney Injury in Patients With Liver Cirrhosis

Interventions

serum creatinine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2024Actual

Primary Completion Date

Oct 15, 2024Actual

Completion Date

Jul 15, 2025Actual

First Submitted Date

Mar 25, 2024

First Submission Date that Met QC Criteria

Apr 1, 2024

First Posted Date

Apr 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2026

Last Update Posted Date

Apr 15, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Shehab Ahmed, Sohag, Egypt, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital.

Detailed Description

Acute kidney injury (AKI) is a common condition in patients with cirrhosis. It occurs in up to 50% of hospitalized patients with cirrhosis and in 58% of such patients in the intensive care unit. AKI is one of the key predictors for short-term mortality in patients with liver cirrhosis with mortality rates as high as 90%. There is a remarkable increase in length of hospital stay with high financial burden on patients with AKI.

In general, the three main causes of AKI are renal hypoperfusion (also referred to as prerenal AKI), which in most cases is due to hypovolemia; intrinsic, structural kidney injury; and postrenal injury due to urinary obstruction. A unique cause of AKI due to renal hypoperfusion in patients with cirrhosis is the hepatorenal syndrome (HRS), which is the result of renal vasoconstriction. Early identification and management of AKI may improve outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A		Cirrhotic patients with Acute kidney injury	Diagnostic Test: serum creatinine
group B		Cirrhotic patients without Acute kidney injury	Diagnostic Test: serum creatinine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum creatinine	Diagnostic Test	to detect patients with Acute kidney injury	group A group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital	Number of new cases of acute kidney injury (which will be diagnosed by either increase in serum creatinine ≥0.3 mg/dl within 48 hours; or, a percentage increase in serum creatinine ≥50% within the prior seven days) occurring in cirrhotic patients in Sohag University Hospital.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhotic patients ( age more than 18 years old ) in Sohag University Hospital

Exclusion Criteria:

patients with known preexisting chronic kidney disease
patients who had undergone renal transplantation
malignancy
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cirrhotic patients ( age more than 18 years old ) in Sohag University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Hospital		Sohag	Sohag Governorate		Egypt