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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Persistent Acute Renal Failure; Acute Kidney Injury; Transient Acute Renal Failure

Treatments: Biological: Data observation

Study type: Observational

Funder types: Other

Identifiers

NCT05247502

RNI 2021 LAUTRETTE

2021-A01472-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 860 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

860 participants in 3 patient groups

ICU patients without Acute Kidney Injury

Description:

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.

Treatment:

Biological: Data observation

ICU patients with transient Acute kidney injury

Description:

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.

Treatment:

Biological: Data observation

ICU patients with persistent Acute kidney injury

Description:

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.

Treatment:

Biological: Data observation