Status:

COMPLETED

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

Lead Sponsor:

Nantes University Hospital

Collaborating Sponsors:

Roche Pharma AG

ThermoFisher Scientific Brahms Biomarkers France

Conditions:

Acute Kidney Injury

Eligibility:

All Genders

18+ years

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%, reac...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 22 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 10 2025

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT05283213

Start Date

November 22 2022

End Date

March 10 2025

Last Update

June 11 2025

Active Locations (1)

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1

Nantes UH

Nantes, France, 44000