Intensive Care Unit ICU, Kidney Injury, Acute
Conditions
Keywords
Acute Kidney Injury, Intensive Care Unit, Epidemiology, major adverse kidney events
Brief 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.
Interventions
None listed
Sponsors
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
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence rate of acute kidney injury | 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 | within 7 days of ICU admission. | maximum severity of acute kidney injury defined by the Kidney Disease: Improving Global Outcomes classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type and specifics of applied renal replacement therapy | within 7 days of ICU admission. | indications, timing, modality, method duration, anticoagulation, discontinuation |
| Hospital readmission up to day 90 | within 90 days of ICU admission | — |
| Serum creatinine level at ICU and hospital discharge (truncated at day 90) | 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 | hospital discharge | Renal Replacement Therapy dependence is defined as the use of renal replacement therapy within 72-hours before hospital discharge |
| Mortality | 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 | 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 |
| Incidence of acute kidney injury and maximum acute kidney injury severity stage defined by serum creatinine criteria only and urine output criteria only | within 7 days of ICU admission. | acute kidney injury is defined and classified by the Kidney Disease: Improving Global Outcomes definition |
| Proportion of episodes with rapid reversal (duration <48h) and persistent acute kidney injury(duration ≥48h) | within 7 days of ICU admission. | acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition |
| Proportion of acute kidney injury in patients with and without known baseline serum creatinine | 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 |
| Duration of acute kidney injury episodes | within 7 days of ICU admission. | acute kidney injury defined by the Kidney Disease: Improving Global Outcomes definition, and duration measured in days |
| Incidence of acute kidney disease | 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 |
| Use of renal replacement therapy within 7 days of ICU admission | within 7 days of ICU admission. | — |
| Length of stay | hospital stay | Length of stay in the ICU, post ICU in the hospital, and total length of stay in the hospital , measured in days |
| ICU readmission up to day 90 | within 90 days of ICU admission | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survival | at 90 days after ICU admission and at 1 year after ICU admission | — |
| Health-related quality of life | at 90 days after ICU admission and at 1 year after ICU admission | Measured with the EuroQol-5D-5L instrument |
| Major Adverse Kidney Events (MAKE): | 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 |
| Mortality | at 90 days after ICU admission and at 1 year after ICU admission | — |
| Renal Replacement Therapy dependence | at 90 days after ICU admission and at 1 year after ICU admission | — |
| Serum creatinine level at day 90, and at1 year | at 90 days after ICU admission and at 1 year after ICU admission | — |
Countries
Belgium
Outcome results
None listed