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

NCT ID: NCT05283213

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2025-03-10

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Early biomarkers of acute kidney injury

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

ThermoFisher Scientific Brahms Biomarkers France

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim Lakhal, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

Nantes UH

Nantes, , France

Countries

France

Other Identifiers

RC22_0108

Identifier Type: -

Identifier Source: org_study_id