Ghent University Hospital
Ghent, 9000, Belgium
NCT Number: NCT07207031
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ghent, 9000, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: within 7 days of ICU admission.
maximum severity of acute kidney injury defined by the Kidney Disease: Improving Global Outcomes classification
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
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
Time frame: within 7 days of ICU admission.
acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition
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
Time frame: within 7 days of ICU admission.
Time frame: within 7 days of ICU admission.
indications, timing, modality, method duration, anticoagulation, discontinuation
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
Time frame: within 90 days of ICU admission
Time frame: within 90 days of ICU admission
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
Time frame: hospital discharge
Renal Replacement Therapy dependence is defined as the use of renal replacement therapy within 72-hours before hospital discharge
Time frame: at hospital discharge or at day 90 after ICU admission if hospital stay is longer than 90 days after ICU admission
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
Time frame: within 7 days of ICU admission.
acute kidney injury is defined and classified by the Kidney Disease: Improving Global Outcomes definition
Time frame: at 90 days after ICU admission and at 1 year after ICU admission
Time frame: at 90 days after ICU admission and at 1 year after ICU admission
Time frame: at 90 days after ICU admission and at 1 year after ICU admission
Time frame: at 90 days after ICU admission and at 1 year after ICU admission
Time frame: at 90 days after ICU admission and at 1 year after ICU admission
Measured with the EuroQol-5D-5L instrument
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
University Hospital, Ghent
Other
Acute Kidney Injury - Epidemiology in Intensive Care Unit Patients 2
Acronym: AKI-EPI2
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.
Published trials that share one or more normalized conditions with this study.
NCT07016074
Acute Kidney Injury, Female Urogenital Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT07030166
Acute Kidney Injury, Female Urogenital Diseases
Nanjing, China
View Trial DetailsNCT07251075
Acute Kidney Injury, Chronic Disease
View Trial DetailsNCT05189262
Acute Kidney Injury, Cardiac Surgery
Baltimore, Maryland, United States
View Trial Details