Clinical trial NCT05247502: Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study
Official title: Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Transient Acute Renal Failure
Persistent Acute Renal Failure
Keywords: follow-up
intensive care unit
chronic kidney disease
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Kidney Event (MAKE) outcome at 3-month
timeFrame: 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
Secondary outcomes:
measure: MAKE outcome at 12-month
timeFrame: 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: CKD (occurence or progression if present before AKI) at 3-month
timeFrame: 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: CKD (occurence or progression if present before AKI) at 12-month
timeFrame: 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: chronic extra-renal epuration or kidney transplantation at 3-month
timeFrame: 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: chronic extra-renal epuration or kidney transplantation at 12-month
timeFrame: 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: Death occurence at 3-months
timeFrame: 3 months after the onset of AKI or 3 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: Death occurence at 12-months
timeFrame: 12 months after the onset of AKI or 12 months after ICU admission for patients without occurrence of AKI during their ICU stay.
measure: MAKE outcome at 3-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive
timeFrame: 3 months after the AKI onset.
measure: MAKE outcome at 12-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive
timeFrame: 12 months after the AKI onset.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean-Perrin
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandre Lautrette
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Cécile Gosset
role: PRINCIPAL_INVESTIGATOR
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