MAKI: Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05247502

Collaborator

(none)

860

Enrollment

Locations

Anticipated Duration (Months)

430

Patients Per Site

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Transient Acute Renal Failure Persistent Acute Renal Failure	Biological: Data observation

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

860 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
ICU patients without Acute Kidney Injury Intensive care unit (ICU) patients who do not develop acute kidney injury (AKI) during their stay. AKI will be defined by KDIGO stage 1. The baseline serum creatinine (sCr) measurement will be defined as the sCr at admission if the corresponding estimation of glomerular filtration rate (GFR) by CKD-EPI formula is at least 90ml/min/1.73m2. Otherwise, the most recent sCr measured from 7-365 days prior to admission will be used. If there is no sCr measurement available from this period, it will be estimated using a reverse CKD-EPI formula for a GFR of 75 ml/min/1.73m2. No intervention is foreseen out of the observation of data relative to kidney function during ICU stay, at 3 month and 12 month of ICU admission. There will be no biological sample collection.	Biological: Data 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.
ICU patients with transient Acute kidney injury Transient AKI will be defined as a complete renal recovery within 48 hours after the start of AKI. Complete renal recovery will be defined as a return to within 25% of the baseline serum creatinine measurement. TIf several AKI episodes occur during the patient's ICU stay, only the longest episode will be considered. No intervention is foreseen out of the observation of data relative to kidney function during ICU stay, at 3 month and 12 month of AKI start. There will be no biological sample collection.	Biological: Data 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.
ICU patients with persistent Acute kidney injury If the AKI episode lasts longer than 48 hours, it will be classified as persistent AKI. If several AKI episodes occur during the patient's ICU stay, only the longest episode will be considered. No intervention is foreseen out of the observation of data relative to kidney function during ICU stay, at 3 month and 12 month of AKI start. There will be no biological sample collection.	Biological: Data 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.

Arm

Intervention/Treatment

ICU patients without Acute Kidney Injury

Intensive care unit (ICU) patients who do not develop acute kidney injury (AKI) during their stay. AKI will be defined by KDIGO stage 1. The baseline serum creatinine (sCr) measurement will be defined as the sCr at admission if the corresponding estimation of glomerular filtration rate (GFR) by CKD-EPI formula is at least 90ml/min/1.73m2. Otherwise, the most recent sCr measured from 7-365 days prior to admission will be used. If there is no sCr measurement available from this period, it will be estimated using a reverse CKD-EPI formula for a GFR of 75 ml/min/1.73m2. No intervention is foreseen out of the observation of data relative to kidney function during ICU stay, at 3 month and 12 month of ICU admission. There will be no biological sample collection.

Biological: Data 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.

ICU patients with transient Acute kidney injury

Transient AKI will be defined as a complete renal recovery within 48 hours after the start of AKI. Complete renal recovery will be defined as a return to within 25% of the baseline serum creatinine measurement. TIf several AKI episodes occur during the patient's ICU stay, only the longest episode will be considered. No intervention is foreseen out of the observation of data relative to kidney function during ICU stay, at 3 month and 12 month of AKI start. There will be no biological sample collection.

Biological: Data observation

ICU patients with persistent Acute kidney injury

If the AKI episode lasts longer than 48 hours, it will be classified as persistent AKI. If several AKI episodes occur during the patient's ICU stay, only the longest episode will be considered. No intervention is foreseen out of the observation of data relative to kidney function during ICU stay, at 3 month and 12 month of AKI start. There will be no biological sample collection.

Biological: Data observation

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Jean-Perrin	Clermont-Ferrand		France
2	CHU clermont-ferrand	Clermont-Ferrand		France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Alexandre Lautrette, University Hospital, Clermont-Ferrand
Principal Investigator: Cécile Gosset, University Hospital, Clermont-Ferrand