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

Overview

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.

Interventions

• 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

Primary outcome measures

• 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.]

Secondary outcome measures (9)

• 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.]
• 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.]
• 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 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

France · 2 centers

• Centre Jean-Perrin — Clermont-Ferrand
• CHU clermont-ferrand — Clermont-Ferrand

Publications

• Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Au PMID 26162677
• Lewington AJ, Cerda J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013 Sep;84(3):457-67. doi: 10.1038/ki.2013.153. Epub 2013 May 1. PMID 23636171
• Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA; Acute Disease Quality Initiative Workgroup 16.. Acute kidney disease and renal recovery: consensus report of the Ac PMID 28239173
• Truche AS, Ragey SP, Souweine B, Bailly S, Zafrani L, Bouadma L, Clec'h C, Garrouste-Orgeas M, Lacave G, Schwebel C, Guebre-Egziabher F, Adrie C, Dumenil AS, Zaoui P, Argaud L, Jamali S, Goldran Toledano D, Marcotte G, Timsit JF, Darmon M. ICU survival and need of renal replacement therapy with respect to AKI duration in critically ill patients. Ann Intensive Care. 2018 Dec 17;8(1):127. doi: 10.11 PMID 30560526
• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available. PMID 22890468
• Perinel S, Vincent F, Lautrette A, Dellamonica J, Mariat C, Zeni F, Cohen Y, Tardy B, Souweine B, Darmon M. Transient and Persistent Acute Kidney Injury and the Risk of Hospital Mortality in Critically Ill Patients: Results of a Multicenter Cohort Study. Crit Care Med. 2015 Aug;43(8):e269-75. doi: 10.1097/CCM.0000000000001077. PMID 25962084
• Coelho S, Fonseca JN, Gameiro J, Jorge S, Velosa J, Lopes JA. Transient and persistent acute kidney injury in acute liver failure. J Nephrol. 2019 Apr;32(2):289-296. doi: 10.1007/s40620-018-00568-w. Epub 2018 Dec 19. PMID 30569444
• Kim CS, Bae EH, Ma SK, Kweon SS, Kim SW. Impact of Transient and Persistent Acute Kidney Injury on Chronic Kidney Disease Progression and Mortality after Gastric Surgery for Gastric Cancer. PLoS One. 2016 Dec 9;11(12):e0168119. doi: 10.1371/journal.pone.0168119. eCollection 2016. PMID 27936153

Identifiers

NCT: NCT05247502 · RNI 2021 LAUTRETTE · 2021-A01472-39

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗