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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10642 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Kidney Injury in Coronavirus Disease-19 (COVID-19) Patients Admitted to the Intensive Care Unit (ICU)

NCT04997915

Critical Illness COVID-19 Pneumonia Acute Kidney Injury

COMPLETED

Acute Kidney Injury in Intensive Care Patients

NCT05970952

Acute Renal Injury Critical Illness

UNKNOWN

Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy

NCT02897310

Critical Illness Acute Kidney Injury

COMPLETED

Acute Kidney Injury in Critical COVID-19: Outcomes and Risks

NCT07089693

COVID -19 Acute Kidney Injury Intensive Care Unit (ICU) Admission +1 more

COMPLETED

PrEvalence of Acute and Chronic Kidney Disease Treated by Renal Replacement Therapy

NCT02341885

Renal Replacement Therapy Acute Kidney Injury Chronic End Stage Kidney Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Injury, Acute Intensive Care Unit ICU

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensive Care Unit patients

adult patients admitted to the intensive care unit

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No