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

NCT04525625 | Unknown

• 1 other identifier: AKI-ACLF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Injury; Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• AKI

  incidence (%) of AKI in patients with AoCLF as defined by Acute Kidney Injury Network guidelines

  28 days after ICU admission

Secondary Outcomes (2)

• arterial to urinary oxygen gradient

  ICU admission, ICU day 1 and ICU dy 3

• mortality

  28-days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institutul Clinic Fundeni: lead

Study Sites (1)

Popescu Mihai

Bucharest, 022328, Romania

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Dana Tomescu, Prof

  Fundeni Clinical Institute

  STUDY CHAIR

Central Study Contacts

Dana Tomescu, Prof

CONTACT

0040722300288; danatomescu@gmail.com

Mihai Popescu, Assoc Prof

CONTACT

mihai.popescu@umfcd.ro

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: February 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

RO (1)