Kidney Injury, AcuteAKI-EPI2NCT07207031

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

An observational study of Kidney Injury, Acute and Intensive Care Unit ICU, run by University Hospital, Ghent at 1 site in Belgium.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Injury, Acute, Intensive Care Unit ICU
How many people: 10,642 participants
Where: 1 siteBelgium
Study dates: 1 Aug 2025to 31 Dec 2027
How long will I take part?: 1 Year
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: adult ICU patients

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site

Ghent University Hospital
Ghent, 9000

Other trials in Belgium

About this study

Official title: Acute Kidney Injury - Epidemiology in Intensive Care Unit Patients 2

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
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07207031
Study group	Role	What they receive
Intensive Care Unit patients		adult patients admitted to the intensive care unit

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: within 7 days of ICU admission.

Secondary outcomes (14)

Proportion of acute kidney injury in patients with and without known baseline serum creatinine
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
Measured: within 7 days of ICU admission.
Duration of acute kidney injury episodes
acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition, and duration measured in days
Measured: within 7 days of ICU admission.
Proportion of episodes with rapid reversal (duration <48h) and persistent acute kidney injury(duration ≥48h)
acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition
Measured: within 7 days of ICU admission.
Incidence of acute kidney disease
acute kidney disease as defined by the Kidney Disease: Improving Global Outcomes definition
Measured: 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
Measured: within 7 days of ICU admission.
Type and specifics of applied renal replacement therapy
indications, timing, modality, method duration, anticoagulation, discontinuation
Measured: within 7 days of ICU admission.
Length of stay
Length of stay in the ICU, post ICU in the hospital, and total length of stay in the hospital , measured in days
Measured: hospital stay
ICU readmission up to day 90
Measured: within 90 days of ICU admission
Hospital readmission up to day 90
Measured: within 90 days of ICU admission
Serum creatinine level at ICU and hospital discharge (truncated at day 90)
Measured: 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
Renal Replacement Therapy dependence at hospital discharge
Renal Replacement Therapy dependence is defined as the use of renal replacement therapy within 72-hours before hospital discharge
Measured: hospital discharge
Mortality
Measured: at hospital discharge or at day 90 after ICU admission if hospital stay is longer than 90 days after ICU admission
Magnitude of acute kidney injury
Magnitude of acute kidney injury: defined as the area under the curve of acute kidney injury severity over time
Measured: within 7 days of ICU admission.
Incidence of acute kidney injury and maximum acute kidney injury severity stage defined by serum creatinine criteria only and urine output criteria only
acute kidney injury is defined and classified by the Kidney Disease: Improving Global Outcomes definition
Measured: within 7 days of ICU admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202531 Dec 2027

First posted3 Oct 2025
Study start1 Aug 2025
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
More trials run by University Hospital, GhentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 10,642 participants (estimated)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT07207031
Sponsor's protocol ID: ONZ-2024-0185
Acronym: AKI-EPI2
Status last verified: Oct 2025
First submitted: 4 Dec 2024
Last updated: 3 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 26162677
Schneider AG, Vandenberghe W, Bellomo R, Forni L, Joannidis M, Jongs N, Kellum JA, Ostermann M, Prowle J, Rimmele T, See E, Zarbock A, Bagshaw SM, Hoste E; AKI EPI 2 Executive Committee. Acute kidney injury-epidemiology in intensive care unit patients 2: study protocol for a prospective international multicentre cohort study. BMJ Open. 2026 Jul 9;16(7):e119063. doi: 10.1136/bmjopen-2026-119063.
PubMed 42425561

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Kidney Injury, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Kidney Injury - Epidemiology in Intensive Care Unit Patients 2
ClinicalTrials.gov ID: NCT07207031
Acronym / sponsor ID: AKI-EPI2 / ONZ-2024-0185
Conditions: Kidney Injury, Acute, Intensive Care Unit ICU
Keywords: Acute Kidney Injury, Intensive Care Unit, Epidemiology, major adverse kidney events
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 10,642 participants (estimated)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: Centre Hospitalier Universitaire Vaudois, Tirol Kiniken GmbH, Austin Hospital, Melbourne Australia, Hospices Civils de Lyon, Royal Surrey County Hospital NHS Foundation Trust, University of Alberta, Universitätsklinkum Münster - Medizinische Klinik und Poliklinik B, St. Bartholomew's Hospital
Study start: 1 Aug 2025 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 3 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
Intensive Care Unit patients	–	–adult patients admitted to the intensive care unit

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: adult ICU patients

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
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

14 secondary outcomes

Proportion of acute kidney injury in patients with and without known baseline serum creatinine
Time frame: within 7 days of ICU admission.
Duration of acute kidney injury episodes
Time frame: within 7 days of ICU admission.
Proportion of episodes with rapid reversal (duration <48h) and persistent acute kidney injury(duration ≥48h)
Time frame: within 7 days of ICU admission.
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.
Use of renal replacement therapy within 7 days of ICU admission
Time frame: within 7 days of ICU admission.
Type and specifics of applied renal replacement therapy
Time frame: within 7 days of ICU admission.
Length of stay
Time frame: hospital stay
ICU readmission up to day 90
Time frame: within 90 days of ICU admission
Hospital readmission up to day 90
Time frame: within 90 days of ICU admission
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
Renal Replacement Therapy dependence at hospital discharge
Time frame: hospital discharge
Mortality
Time frame: at hospital discharge or at day 90 after ICU admission if hospital stay is longer than 90 days after ICU admission
Magnitude of acute kidney injury
Time frame: within 7 days of ICU admission.
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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Background: PubMed 26162677Hoste 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.
Derived from this study: PubMed 42425561Schneider AG, Vandenberghe W, Bellomo R, Forni L, Joannidis M, Jongs N, Kellum JA, Ostermann M, Prowle J, Rimmele T, See E, Zarbock A, Bagshaw SM, Hoste E; AKI EPI 2 Executive Committee. Acute kidney injury-epidemiology in intensive care unit patients 2: study protocol for a prospective international multicentre cohort study. BMJ Open. 2026 Jul 9;16(7):e119063. doi: 10.1136/bmjopen-2026-119063.
Individual participant dataSharing planned: Undecided

Related trials for Kidney Injury, Acute

Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
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Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Eric Hoste, MD, PhD principal investigator

University Hospital, Ghent

Antoine Schneider, MD, PhD principal investigator

Centre Hospitalier Universitaire Vandois (CHUV)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Injury, Acute and Intensive Care Unit ICU, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence rate of acute kidney injury (time frame: within 7 days of ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07207031, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.