Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure

Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. As kidney ischemia is one of the main mechanisms responsible for AKI in AoCLF, an increase in urinary to arterial partial pressure of oxygen may help in the early diagnosis of renal failure. For this arterial and urinary oxygen pressure will be measured at ICU admission, on day 1 and day 3 of ICU stay. Diagnosis of AKI within the first 28 days after ICU admission will be recorded

Study Overview

• Status: Recruiting
• Conditions: Acute-On-Chronic Liver Failure; Acute Kidney Injury

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 022328
    • Recruiting
    • Popescu Mihai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted to a general ICU for ACLF who fall into the inclusion and exclusion criteria. Standard treatment will be applied to all patients and no supplemental intervention is required for the present study.

Description

Inclusion Criteria:

- patients admitted to the ICU for acute-on-chronic liver failure

Exclusion Criteria:

• pre-existing renal disease
• urine output<200 mL/day
• death within the first 24 hours after ICU admission
• emergency liver transplantation within the follow-up period (28 days)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI	incidence (%) of AKI in patients with AoCLF as defined by Acute Kidney Injury Network guidelines	28 days after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial to urinary oxygen gradient	mathematical difference in oxygen partial pressure between arterial blood and urine (mmHg) in patients with AKI compared to patients without AKI	ICU admission, ICU day 1 and ICU dy 3
mortality	28-day mortality	28-days

Collaborators and Investigators

• Sponsor: Institutul Clinic Fundeni

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Liver Failure, Acute; Renal Insufficiency; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: AKI-ACLF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No