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

Recruiting

• Conditions: Transient Acute Renal Failure; Persistent Acute Renal Failure; Acute Kidney Injury
• Interventions: Biological: Data observation

• Registration Number: NCT05247502
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Study Start: 2022-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2028-11-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 860

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients with persistent Acute kidney injury	Data observation	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.
ICU patients with transient Acute kidney injury	Data observation	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.
ICU patients without Acute Kidney Injury	Data observation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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
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.
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.
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.
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 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.

Trial Locations

Locations (2)

Centre Jean-Perrin; 🇫🇷 Clermont-Ferrand, France

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France