Acute Kidney InjuryMAKINCT05247502
Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study
An observational study of Acute Kidney Injury and Transient Acute Renal Failure, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Transient Acute Renal Failure, Persistent Acute Renal Failure
- What is being tested?
- Data observation
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Nov 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients who are hospitalized for more than 24 hours in ICU will be eligible to participate in the study.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Centre Jean-Perrin
Clermont-Ferrand
CHU clermont-ferrand
Clermont-Ferrand
About this 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.
Read the 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.
- Being tested
- Data observation
- Keywords
- follow-up, intensive care unit, chronic kidney disease
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data observationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Data observation | |
| 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. Receives: Biological: Data observation | |
| 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. Receives: Biological: Data observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Kidney Event (MAKE) outcome at 3-month
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
Measured: 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 (9)
MAKE outcome at 12-month
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
This information will be recorded through a phone call.
Measured: 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
This information will be recorded through a phone call.
Measured: 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
This information will be recorded through a phone call.
Measured: 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
This information will be recorded through a phone call.
Measured: 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
The main pathophysiological mechanisms will be defined retrospectively by a board of nephrologist experts.
Measured: 3 months after the AKI onset.
MAKE outcome at 12-month according to the main pathophysiological mechanism of AKI: pre-renal, organic, or obstructive
The main pathophysiological mechanisms will be defined retrospectively by a board of nephrologist experts.
Measured: 12 months after the AKI onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: due to a lack of funding and human resources to carry out data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Lautrette, Principal investigator, University Hospital, Clermont-FerrandCécile Gosset, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247502
- Sponsor's protocol ID
- RNI 2021 LAUTRETTE
- Other IDs
- 2021-A01472-39
- Acronym
- MAKI
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Lewington 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.
PubMed 23636171Chawla 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 Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27.
PubMed 28239173Truche 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: 10.1186/s13613-018-0467-6.
PubMed 30560526Khwaja 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.
PubMed 22890468Perinel 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.
PubMed 25962084Coelho 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.
PubMed 30569444Kim 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.
PubMed 27936153Bhatraju PK, Mukherjee P, Robinson-Cohen C, O'Keefe GE, Frank AJ, Christie JD, Meyer NJ, Liu KD, Matthay MA, Calfee CS, Christiani DC, Himmelfarb J, Wurfel MM. Acute kidney injury subphenotypes based on creatinine trajectory identifies patients at increased risk of death. Crit Care. 2016 Nov 17;20(1):372. doi: 10.1186/s13054-016-1546-4.
PubMed 27852290Horne KL, Packington R, Monaghan J, Reilly T, McIntyre CW, Selby NM. The effects of acute kidney injury on long-term renal function and proteinuria in a general hospitalised population. Nephron Clin Pract. 2014;128(1-2):192-200. doi: 10.1159/000368243. Epub 2014 Nov 28.
PubMed 25472765Horne KL, Packington R, Monaghan J, Reilly T, Selby NM. Three-year outcomes after acute kidney injury: results of a prospective parallel group cohort study. BMJ Open. 2017 Mar 29;7(3):e015316. doi: 10.1136/bmjopen-2016-015316.
PubMed 28360257Forni LG, Darmon M, Ostermann M, Oudemans-van Straaten HM, Pettila V, Prowle JR, Schetz M, Joannidis M. Renal recovery after acute kidney injury. Intensive Care Med. 2017 Jun;43(6):855-866. doi: 10.1007/s00134-017-4809-x. Epub 2017 May 2.
PubMed 28466146Heung M, Steffick DE, Zivin K, Gillespie BW, Banerjee T, Hsu CY, Powe NR, Pavkov ME, Williams DE, Saran R, Shahinian VB; Centers for Disease Control and Prevention CKD Surveillance Team. Acute Kidney Injury Recovery Pattern and Subsequent Risk of CKD: An Analysis of Veterans Health Administration Data. Am J Kidney Dis. 2016 May;67(5):742-52. doi: 10.1053/j.ajkd.2015.10.019. Epub 2015 Dec 12.
PubMed 26690912See EJ, Toussaint ND, Bailey M, Johnson DW, Polkinghorne KR, Robbins R, Bellomo R. Risk factors for major adverse kidney events in the first year after acute kidney injury. Clin Kidney J. 2019 Dec 20;14(2):556-563. doi: 10.1093/ckj/sfz169. eCollection 2021 Feb.
PubMed 33623679Bucaloiu ID, Kirchner HL, Norfolk ER, Hartle JE 2nd, Perkins RM. Increased risk of death and de novo chronic kidney disease following reversible acute kidney injury. Kidney Int. 2012 Mar;81(5):477-85. doi: 10.1038/ki.2011.405. Epub 2011 Dec 7.
PubMed 22157656
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05247502
- Acronym / sponsor ID
- MAKI / RNI 2021 LAUTRETTE
- Keywords
- follow-up, intensive care unit, chronic kidney disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to a lack of funding and human resources to carry out data collection
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICU patients without Acute Kidney Injury | – | Biological: Data observationIntensive 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. |
| ICU patients with transient Acute kidney injury | – | Biological: Data observationTransient 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. |
| ICU patients with persistent Acute kidney injury | – | Biological: Data observationIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who are hospitalized for more than 24 hours in ICU will be eligible to participate in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data observationAt 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. | Biological | ICU patients with persistent Acute kidney injury, ICU patients with transient Acute kidney injury, ICU patients without Acute Kidney Injury |
Primary outcome
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
9 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: due to a lack of funding and human resources to carry out data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 26162677Hoste 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 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Background: PubMed 23636171Lewington 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.
- Background: PubMed 28239173Chawla 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 Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27.
- Background: PubMed 30560526Truche 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: 10.1186/s13613-018-0467-6.
- Background: PubMed 22890468Khwaja 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.
- Background: PubMed 25962084Perinel 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.
- Background: PubMed 30569444Coelho 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.
- Background: PubMed 27936153Kim 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.
- Background: PubMed 27852290Bhatraju PK, Mukherjee P, Robinson-Cohen C, O'Keefe GE, Frank AJ, Christie JD, Meyer NJ, Liu KD, Matthay MA, Calfee CS, Christiani DC, Himmelfarb J, Wurfel MM. Acute kidney injury subphenotypes based on creatinine trajectory identifies patients at increased risk of death. Crit Care. 2016 Nov 17;20(1):372. doi: 10.1186/s13054-016-1546-4.
- Background: PubMed 25472765Horne KL, Packington R, Monaghan J, Reilly T, McIntyre CW, Selby NM. The effects of acute kidney injury on long-term renal function and proteinuria in a general hospitalised population. Nephron Clin Pract. 2014;128(1-2):192-200. doi: 10.1159/000368243. Epub 2014 Nov 28.
- Background: PubMed 28360257Horne KL, Packington R, Monaghan J, Reilly T, Selby NM. Three-year outcomes after acute kidney injury: results of a prospective parallel group cohort study. BMJ Open. 2017 Mar 29;7(3):e015316. doi: 10.1136/bmjopen-2016-015316.
- Background: PubMed 28466146Forni LG, Darmon M, Ostermann M, Oudemans-van Straaten HM, Pettila V, Prowle JR, Schetz M, Joannidis M. Renal recovery after acute kidney injury. Intensive Care Med. 2017 Jun;43(6):855-866. doi: 10.1007/s00134-017-4809-x. Epub 2017 May 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Lautrette principal investigator
University Hospital, Clermont-Ferrand
Cécile Gosset principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Transient Acute Renal Failure, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to a lack of funding and human resources to carry out data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247502, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.