Acute Kidney Injury, Persistent Acute Renal Failure, Transient Acute Renal Failure
Conditions
Keywords
follow-up, intensive care unit, chronic kidney disease
Brief summary
The purpose of this study is to assess the impact of Acute Kidney Injury (AKI) characteristics on long-term renal prognosis in Intensive Care Unit (ICU) patients.
Detailed description
This study will be a multicentre prospective observational study. The MAKE evaluation after different kind of Acute Kidney Injury (MAKI) study will be conducted in 4 Intensive Care Units (ICU) in Clermont-Ferrand, France. An information form about the study will be given to each ICU patients hospitalized more than 24 hours. This form will be given to their support person if it is not possible. Data during ICU stay related to renal function of patients included in the study will be collected. If available data related to their baseline kidney function (before ICU hospitalisation) will be collected. The patients will be classified into 3 groups based on the occurrence of AKI and its duration: 1) patients without AKI during their stay, 2) patients who had a transient AKI episode (defined as recovery within 48 hours of onset), and 3) patients who had a persistent AKI episode during their stay.
Interventions
BIOLOGICALData observation
At the time of participant inclusion in the study, demographic data and a baseline serum creatinine measurement will be collected. During the patient's ICU stay, the occurrence and duration of any AKI episode will be recorded. Data related to diagnostic examinations of these AKI episodes will also be collected in accordance with practices guidelines. Data related to AKI monitoring will also be collected, including serum creatinine and urea daily follow-up measurements, diuresis, and nephrotoxic use. The patient's need for extrarenal epuration or use of catecholamines will also be recorded. In the 3-month and 12-month.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who are hospitalized for more than 24 hours in ICU will be eligible to participate in the study.
Exclusion criteria
* patients who are younger than 18 years, * those who are pregnant, * those who have chronic extrarenal epuration before their admission to the ICU, * those who are admitted for kidney transplantation, * those under the safeguard of justice, and those who refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Kidney Event (MAKE) outcome at 3-month | 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay. | MAKE includes three main components: * Chronic Kidney Disease (CKD) occurrence or progression: Among patients who did not have CKD prior to the hospitalization, CKD occurrence is defined as a 25% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements compared to the baseline estimation and achievement of CKD stage 3 or higher. Progression of CKD in patients with pre-existing CKD at the time of hospitalization (preadmission estimated GFR \< 60ml/min/1.73m2) is defined as a 50% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements and achievement of CKD stage 5 or receipt of chronic extrarenal epuration or kidney transplant (15,47). * Need for chronic extrarenal epuration * Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAKE outcome at 12-month | 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay. | MAKE includes three main components: * Chronic Kidney Disease (CKD) occurrence or progression: Among patients who did not have CKD prior to the hospitalization, CKD occurrence is defined as a 25% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements compared to the baseline estimation and achievement of CKD stage 3 or higher. Progression of CKD in patients with pre-existing CKD at the time of hospitalization (preadmission estimated GFR \< 60ml/min/1.73m2) is defined as a 50% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements and achievement of CKD stage 5 or receipt of chronic extrarenal epuration or kidney transplant. * Need for chronic extrarenal epuration * Death |
| CKD (occurence or progression if present before AKI) at 3-month | 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay. | Chronic Kidney Disease (CKD) occurrence or progression: Among patients who did not have CKD prior to the hospitalization, CKD occurrence is defined as a 25% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements compared to the baseline estimation and achievement of CKD stage 3 or higher. Progression of CKD in patients with pre-existing CKD at the time of hospitalization (preadmission estimated GFR \< 60ml/min/1.73m2) is defined as a 50% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements and achievement of CKD stage 5 or receipt of chronic extrarenal epuration or kidney transplant. |
| CKD (occurence or progression if present before AKI) at 12-month | 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay. | Chronic Kidney Disease (CKD) occurrence or progression: Among patients who did not have CKD prior to the hospitalization, CKD occurrence is defined as a 25% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements compared to the baseline estimation and achievement of CKD stage 3 or higher. Progression of CKD in patients with pre-existing CKD at the time of hospitalization (preadmission estimated GFR \< 60ml/min/1.73m2) is defined as a 50% or greater reduction in estimated GFR at 3-month or 12-month posthospitalization measurements and achievement of CKD stage 5 or receipt of chronic extrarenal epuration or kidney transplant. |
| chronic extra-renal epuration or kidney transplantation at 3-month | 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay. | This information will be recorded through a phone call. |
| chronic extra-renal epuration or kidney transplantation at 12-month | 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay. | This information will be recorded through a phone call. |
| Death occurence at 3-months | 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay. | This information will be recorded through a phone call. |
| Death occurence at 12-months | 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay. | This information will be recorded through a phone call. |
| MAKE outcome at 3-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive | 3 months after the AKI onset. | The main pathophysiological mechanisms will be defined retrospectively by a board of nephrologist experts. |
| MAKE outcome at 12-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive | 12 months after the AKI onset. | The main pathophysiological mechanisms will be defined retrospectively by a board of nephrologist experts. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAlexandre Lautrette
University Hospital, Clermont-Ferrand
PRINCIPAL_INVESTIGATORCécile Gosset
University Hospital, Clermont-Ferrand
Outcome results
None listed