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NCT Number: NCT05247502

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

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.

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Key information

Conditions

Acute Kidney Injury Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Acute Renal Failure Renal Insufficiency Renal Insufficiency, Chronic Transient Acute Renal Failure Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU clermont-ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data observation

Biological

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: MAKI

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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