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Enrolling by Invitation

NCT Number: NCT07207031

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. occurrence rate of acute kidney injury

    Time frame: within 7 days of ICU admission

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

  2. maximum severity of acute kidney injury

    Time frame: within 7 days of ICU admission.

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

Secondary outcomes

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

    Time frame: within 7 days of ICU admission.

    acute kidney injury as defined by the Kidney Disease: Improving Global Outcomes definition in patients with known baseline serum creatinine and in those without known baseline serum creatinine

  2. Duration of acute kidney injury episodes

    Time frame: within 7 days of ICU admission.

    acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition, and duration measured in days

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

    Time frame: within 7 days of ICU admission.

    acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition

  4. Incidence of acute kidney disease

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

    acute kidney disease as defined by the Kidney Disease: Improving Global Outcomes definition

  5. Use of renal replacement therapy within 7 days of ICU admission

    Time frame: within 7 days of ICU admission.

  6. Type and specifics of applied renal replacement therapy

    Time frame: within 7 days of ICU admission.

    indications, timing, modality, method duration, anticoagulation, discontinuation

  7. Length of stay

    Time frame: hospital stay

    Length of stay in the ICU, post ICU in the hospital, and total length of stay in the hospital , measured in days

  8. ICU readmission up to day 90

    Time frame: within 90 days of ICU admission

  9. Hospital readmission up to day 90

    Time frame: within 90 days of ICU admission

  10. Serum creatinine level at ICU and hospital discharge (truncated at day 90)

    Time frame: at discharge of the ICU and of the hospital, or day 90 after ICU admission if hospital stay is longer than 90 days after ICU admission

  11. Renal Replacement Therapy dependence at hospital discharge

    Time frame: hospital discharge

    Renal Replacement Therapy dependence is defined as the use of renal replacement therapy within 72-hours before hospital discharge

  12. Mortality

    Time frame: at hospital discharge or at day 90 after ICU admission if hospital stay is longer than 90 days after ICU admission

  13. Magnitude of acute kidney injury

    Time frame: within 7 days of ICU admission.

    Magnitude of acute kidney injury: defined as the area under the curve of acute kidney injury severity over time

  14. Incidence of acute kidney injury and maximum acute kidney injury severity stage defined by serum creatinine criteria only and urine output criteria only

    Time frame: within 7 days of ICU admission.

    acute kidney injury is defined and classified by the Kidney Disease: Improving Global Outcomes definition

Other outcomes

  1. Serum creatinine level at day 90, and at1 year

    Time frame: at 90 days after ICU admission and at 1 year after ICU admission

  2. Renal Replacement Therapy dependence

    Time frame: at 90 days after ICU admission and at 1 year after ICU admission

  3. Mortality

    Time frame: at 90 days after ICU admission and at 1 year after ICU admission

  4. Survival

    Time frame: at 90 days after ICU admission and at 1 year after ICU admission

  5. Health-related quality of life

    Time frame: at 90 days after ICU admission and at 1 year after ICU admission

    Measured with the EuroQol-5D-5L instrument

  6. Major Adverse Kidney Events (MAKE):

    Time frame: at 90 days after ICU admission and at 1 year after ICU admission

    Major Adverse Kidney Events (MAKE): a composite endpoint of death, use of RRT and decreased kidney function

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

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

Registry information

Official study title

Acute Kidney Injury - Epidemiology in Intensive Care Unit Patients 2

Acronym: AKI-EPI2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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