Clinical trial NCT05283213: Development of an Innovative Clinico-biological Score for the Early Detection of Acute Renal Failure Associated With Cardiac Surgery.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: AKI, extracorporal circulation, nephroprotection
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: ThermoFisher Scientific Brahms Biomarkers France
First posted: 2022-03-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing scheduled, combined, cardiac surgery with CC inducing possible acute kidney injury as a consequence

Brief 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 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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: composite score
timeFrame: From pre-CC to 6th hour post CC
Secondary outcomes:
measure: 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)
timeFrame: From pre-CC to 6th hour post CC
measure: 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)
timeFrame: From pre-CC to 6th hour post CC
measure: Score and biomarkers performance for prediction
timeFrame: From pre-CC to 6th hour post CC
measure: Algorithm
timeFrame: From pre-CC to 6th hour post CC
measure: 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)
timeFrame: beyond 48th hour post CC to 7 days
measure: Sensitivity analysis
timeFrame: At 7th days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes UH
Study officials:
affiliation: Nantes UH
name: Karim Lakhal, MD
role: PRINCIPAL_INVESTIGATOR
References: