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

NCT07207031 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 10642

Last updated 2025-10-03

No results posted yet for this study

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER
  • Tirol Kiniken GmbH

    collaborator OTHER
  • Austin Hospital, Melbourne Australia

    collaborator OTHER
  • Hospices Civils de Lyon

    collaborator OTHER
  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Universitätsklinkum Münster - Medizinische Klinik und Poliklinik B

    collaborator OTHER
  • St. Bartholomew's Hospital

    collaborator OTHER
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Eric Hoste, MD, PhD · University Hospital, Ghent

  • Antoine Schneider, MD, PhD · Centre Hospitalier Universitaire Vandois (CHUV)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207031 on ClinicalTrials.gov