Acute Kidney Injury - Epidemiology in Intensive Care Unit Patients 2: an International Multicenter Cohort Study

NCT07207031 | Enrolling By Invitation

• 1 other identifier: ONZ-2024-0185
• Study Type: observational
• Target: 10,642
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn the epidemiology and outcomes of acute kidney injury in critically ill adult patients admited to the intensive care unit (ICU). The main questions it aims to answer are:To provide a contemporary update on the epidemiology (rates, severity, duration, and etiology) of acute kidney injury and associated outcomes in critically ill patients. The co-primary outcomes are:

• occurrence rate of acute kidney injury within 7 days of ICU admission
• maximum severity of acute kidney injury within 7 days of ICU admission. Secondary outcomes:
• Proportion of acute kidney injury in patients with and without known baseline serum creatinine
• Duration of acute kidney injury episodes (within first week of ICU admission)
• Proportion of episodes with rapid reversal (duration \<48h) versus persistent acute kidney injury (duration ≥48h)
• Incidence of acute kidney disease at ICU discharge and hospital discharge, truncated at 90-d
• Use of Renal Replacement Therapy within 7 days of ICU admission
• Type and specifics of applied Renal Replacement Therapy (indications, timing, modality, method duration, anticoagulation, discontinuation)
• ICU lenght of stay (ICU LOS), Hospital lenght of stay (Hospital LOS)
• ICU readmission up to day 90
• Hospital readmission up to day 90
• Serum creatinine level at ICU and hospital discharge (truncated at day 90)
• RRT dependence at hospital discharge (any RRT applied within 72 hours of discharge)
• Mortality at hospital discharge (truncated at 90-d)
• Magnitude of acute kidney injury: area under the curve of acute kidney injury severity over time
• Incidence of acute kidney injury and maximum acute kidney injury severity stage defined by serum creatinine and/or urine output criteria only, within 7 days of ICU admission. Additional endpoints for patients included in the "long term outcomes substudy":
• Serum creatinine level at day 90, and 1 y
• Renal Replacement Therapy dependence at day 90, and 1y
• Mortality at hospital discharge at day 90, and 1y
• Survival analysis up to day 90 and 1 y
• Health-related quality of life at day 90 and 1y
• Major Adverse Kidney Events (MAKE): a composite endpoint of death, use of Renal Replacement Therapy and decreased kidney function at day 90, and 1 year.

Conditions

Kidney Injury, Acute; Intensive Care Unit ICU

Keywords

Acute Kidney Injury; Intensive Care Unit; Epidemiology; major adverse kidney events

Outcome Measures

Primary Outcomes (2)

• occurrence rate of acute kidney injury

  occurrence rate of acute kidney injury in adult patients admitted to the ICU and defined by the Kidney Disease: Improving Global Outcomes defintion

  within 7 days of ICU admission

• maximum severity of acute kidney injury

  maximum severity of acute kidney injury defined by the Kidney Disease: Improving Global Outcomes classification

  within 7 days of ICU admission.

Secondary Outcomes (14)

• Proportion of acute kidney injury in patients with and without known baseline serum creatinine

  within 7 days of ICU admission.

• Duration of acute kidney injury episodes

  within 7 days of ICU admission.

• Proportion of episodes with rapid reversal (duration <48h) and persistent acute kidney injury(duration ≥48h)

  within 7 days of ICU admission.

• Incidence of acute kidney disease

  at ICU discharge and at hospital discharge, or at 90-days in case hospital admission is longer than 90 days.

• Use of renal replacement therapy within 7 days of ICU admission

  within 7 days of ICU admission.

Other Outcomes (6)

• Serum creatinine level at day 90, and at1 year

  at 90 days after ICU admission and at 1 year after ICU admission

• Renal Replacement Therapy dependence

  at 90 days after ICU admission and at 1 year after ICU admission

• Mortality

  at 90 days after ICU admission and at 1 year after ICU admission

Study Arms (1)

Intensive Care Unit patients

adult patients admitted to the intensive care unit

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

adult ICU patients

You may qualify if:

• Age \>=18 y
• Admitted to a participating ICU.
• Admitted to the ICU for more than 24-h, or anticipated length of stay in the ICU for 24-h or more.
• Informed Consent according to local ethical committee

You may not qualify if:

• End Stage Kidney Disease treated with maintenance renal replacement therapy
• Readmission to the ICU during same hospitalization episode
• Missing acute kidney injury defining data (no measured serum creatinine and \<6 hours of documented urinary output)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Centre Hospitalier Universitaire Vaudois: collaborator
• Tirol Kiniken GmbH: collaborator
• Austin Hospital, Melbourne Australia: collaborator
• Hospices Civils de Lyon: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator
• University of Alberta: collaborator
• Universitätsklinkum Münster - Medizinische Klinik und Poliklinik B: collaborator
• St. Bartholomew's Hospital: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.

  PMID: 26162677 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Eric Hoste, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Antoine Schneider, MD, PhD

  Centre Hospitalier Universitaire Vandois (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: October 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

BE (1)