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

November 23, 2022 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

860

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Clermont-Ferrand
        • Principal Investigator:
          • Emmanuel FUTIER
      • Clermont-Ferrand, France
        • Recruiting
        • Centre Jean-Perrin
        • Principal Investigator:
          • Alexandre LAUTRETTE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The MAKI study will recruit a large population of ICU patients. Patients who are hospitalized for more than 24 hours in ICU will be eligible to participate in the study. The MAKE evaluation after different kind of Acute Kidney Injury (MAKI) study will be conducted in 4 ICUs in Clermont-Ferrand, France. All ICU units include both medical and surgical patient recruitment.

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Kidney Event (MAKE) outcome at 3-month
Time Frame: 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
3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAKE outcome at 12-month
Time Frame: 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
12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
CKD (occurence or progression if present before AKI) at 3-month
Time Frame: 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.
3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
CKD (occurence or progression if present before AKI) at 12-month
Time Frame: 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.
12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
chronic extra-renal epuration or kidney transplantation at 3-month
Time Frame: 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.
3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
chronic extra-renal epuration or kidney transplantation at 12-month
Time Frame: 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.
12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
Death occurence at 3-months
Time Frame: 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.
3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
Death occurence at 12-months
Time Frame: 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.
12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
MAKE outcome at 3-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive
Time Frame: 3 months after the AKI onset.
The main pathophysiological mechanisms will be defined retrospectively by a board of nephrologist experts.
3 months after the AKI onset.
MAKE outcome at 12-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive
Time Frame: 12 months after the AKI onset.
The main pathophysiological mechanisms will be defined retrospectively by a board of nephrologist experts.
12 months after the AKI onset.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 LAUTRETTE
  • 2021-A01472-39 (Other Identifier: 2021-A01472-39)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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