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Acute Kidney InjuryDETECT-AKINCT05283213

Development of an Innovative Clinico-biological Score for the Early Detection of Acute Renal Failure Associated With Cardiac Surgery.

An observational study of Acute Kidney Injury, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prediction and early detection of acute renal failure associated with cardiac surgery (ARF-CS) are desirable in order to try to reduce its magnitude. Indeed, its incidence is high (29 to 36%, reaching up to 81% in some series, depending on the vulnerability of the target population) and its consequences are often… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
Early biomarkers of acute kidney injury
How many people
400 participants
Where
1 siteFrance
Study dates
22 Nov 2022to 10 Mar 2025
How long will I take part?
2 Months
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults undergoing scheduled, combined, cardiac surgery with CC inducing possible acute kidney injury as a consequence

Who may be able to join

  • Adults undergoing scheduled, combined, cardiac surgery with CEC.
  • "Combined" cardiac surgery (as opposed to simple cardiac surgery, which is less likely to result in ARF-CC) involves:
  • 2 heart valves (and possibly other procedures) or ≥2 types of procedures among coronary artery bypass graft(s), valve, myocardial, and thoracic aortic surgery.
  • A "scheduled" surgical procedure implies that the patient was added to the operative schedule more than 24 hours before the procedure.

Who cannot join

  • unscheduled cardiac surgery
  • at least one session of extra-renal purification in the week prior to surgery
  • Patient refusal to participate in this research,
  • participation in a study with a possible impact on the incidence of AKI-CC
  • pregnant woman
  • minor, adult under guardianship, protected person.
Show all 10Show fewer
  • no biomarker concentrations were measured and no clinico-biological scores were determined,
  • no pre-CEC creatinine assay is available,
  • the patient dies before H48 unless AKI-CC has occurred in the interim,
  • the patient withdraws consent to participate in the study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nantes UH

    Nantes, 44000

Other trials in France

About this study

Official title: Elaboration d'un Score Clinico-biologique Innovant Pour la détection précoce de l'Insuffisance rénale aiguë associée à la chirurDevelopment of an Innovative Clinico-biological Score for the Early Detection of Acute Renal Failure Associated With Cardiac Surgery. Gie Cardiaque. Monocentric Prospective Study

The prediction and early detection of acute renal failure associated with cardiac surgery (ARF-CS) are desirable in order to try to reduce its magnitude. Indeed, its incidence is high (29 to 36%, reaching up to 81% in some series, depending on the vulnerability of the target population) and its consequences are often serious: prolongation of the length of stay in the intensive care unit and in hospital, death, and evolution towards chronic renal failure, possibly end-stage (justifying long-term extra-renal purification and/or renal transplantation). The challenge is all the more crucial given the high volume of cardiac surgery. In this context, the objective of identifying early on patients at high risk of developing AKI-CC - and therefore eligible for "nephroprotective" measures has generated, in the last decade, a strong interrest around preoperative scores and biomarkers. Thus, more than ten models predicting AKI-CC have been developed and more than 150 candidate biomarkers have been identified since 2004. This insterest is not waning. The DETECT-AKI project aims to evaluate, in a large population (N=400 patients) with varied patient profiles, not only the performance of the most innovative and promising preoperative scores and biomarkers described in the literature, but also the combination of biomarkers with relevant perioperative clinical and biological data in the framework of a clinico-biological score for the early identification of AKI-CC

Read the detailed description

The DETECT-AKI study aims at establishing an innovative composite score, the basis for decision making in the early initiation of nephroprotection measures. This score will include early clinical and biological data before, during and after surgery and may therefore include one or more modern biomarkers. The DETECT-AKI study foresees from the outset the internal validation of the score by bootstrap method: first essential step for the subsequent application of the established score. This is also one of the strengths of the study.

Being tested
Early biomarkers of acute kidney injury
Keywords
AKI, extracorporal circulation, nephroprotection
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early biomarkers of acute kidney injuryDiagnostic test

    The biomarkers tested will be:

    • creatinine levels [pre-, post-CC, H6],
    • Plasma NGAL [Pre-, Post-CC, H6].
    • Urinary NGAL [H6]
    • Plasma cystatin C [Pre-CC, Post-CEC \& H6],
    • plasma HI [pre-, post-CC, H6],
    • plasma IL-6 [post-CC, H6],
    • uremia [pre-, post-CC, H6],
    • urinary DKK3 [pre-CC],
    • urinary CCL-14 [H6],
    • plasma angiopoietin-2 [H6],
    • plasma PENK-A [H6]

    These biomarkers will, if necessary, be corrected for hemodilution or dilution of urine, if any, using [pre-, post-CC, H6] protein and [pre-, post-CC, H6] creatinine, respectively.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite score

    The primary endpoint will be ASCroc associated with the DETECT-AKI composite score established at H6.

    AKI-CC will be based on the current international definition (elevation of creatinine and/or occurrence of oliguria within 48 h postoperatively). Internal validation of the score will be based on a bootstrap resampling method.

    Measured: From pre-CC to 6th hour post CC

Secondary outcomes (6)

  1. Early renal biomarkers performance (creatininemia, urinary TIMP*IGFBP7, plasma and urinary NGAL, plasma Cystatin C / Plasma Hemolysis Index (PH) / interleukin-6, uremia and urinary DKK3)

    Comparison of individual biomarker performance in identifying AKI-CC (all stages) at or before the 6th hour post-CC. The performance of an isolated measurement (at a given perioperative time) of a given biomarker will be analyzed, as well as the variation over time of the concentration of this biomarker (diagnostic performance of the biomarker kinetics).

    Measured: From pre-CC to 6th hour post CC

  2. Score performance of early renal biomarkers (creatininemia, urinary CCL-14, plasma and urinary NGAL, plasma Cystatin C, IH, IL6, angiopoietin-2, PENK-A, uremia and urinary DKK3)

    Comparison of the performance of scores proposed in the literature for the prediction of AKI-CC (all stages) on pre-operative data:

    • Cleveland Clinic Foundation score (dialysis risk for severe AKI (grade III) after cardiac surgery from 0 to 13 (highest risk)
    • Mehta score (calculator that estimates the risk of dialysis after cardiac surgery on demographic and antecedent data for severe AKI (grade III)
    • Ng score (same as Metha score without endocarditis data)
    • Simplified Predictive Index (for renal replacement therapy (RRT) after cardiac surgery from 0 to 8 (highest risk)
    • Leicester score (predicts CSA-AKI of any stage after cardiac surgery using a formula taking into account KDIGO stage but without diuresis)
    • EuroSCORE II (calculator that estimates the risk of dialysis after cardiac surgery on demographic, antecedent data using a formula)

    Measured: From pre-CC to 6th hour post CC

  3. Score and biomarkers performance for prediction

    Comparison of the individual performances of scores and biomarkers for the prediction or early detection of moderate to severe AKI-CC (KDIGO stages II and III), rather than AKI-CC of any stage.

    Measured: From pre-CC to 6th hour post CC

  4. Algorithm

    Construction of a triage algorithm for early classification of patients according to risk of developing AKI-CC (any stage) with pre-operative data as well as per-operative and early post-operative data

    Measured: From pre-CC to 6th hour post CC

  5. Biomarkers performance in AKI persistance (creatininemia, urinary TIMP*IGFBP7, plasma and urinary NGAL, plasma Cystatin C / Plasma Hemolysis Index (PH) / interleukin-6, uremia and urinary DKK3)

    Evaluation of the performance of biomarkers to predict the transient or persistent nature of AKI-CC beyond the 48th hour in patients who have developed AKI-CC.

    Measured: beyond 48th hour post CC to 7 days

  6. Sensitivity analysis

    Sensitivity analysis: analysis of the performance of the composite score using

    • the strict KDIGO definition of AKI-CC, i.e. setting the observation time for the criterion "relative rise in creatinine" at 7 days.
    • omitting the diuresis criterion from the definition, as diuresis is sometimes considered misleading in the context of cardiac surgery (due to the frequent use of diuretics, for example).

    Measured: At 7th days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start22 Nov 2022
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

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
400 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05283213
Sponsor's protocol ID
RC22_0108
Acronym
DETECT-AKI
Status last verified
Jan 2026
First submitted
23 Feb 2022
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury, run by Nantes University Hospital at 1 site 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

composite score (time frame: From pre-CC to 6th hour post CC). 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 NCT05283213.

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 26 Jan 2026.

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