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

NCT05283213 | Completed

• 1 other identifier: RC22_0108
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury

Keywords

AKI, extracorporal circulation, nephroprotection

Outcome Measures

Primary Outcomes (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.

  From pre-CC to 6th hour post CC

Secondary Outcomes (6)

• 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)

  From pre-CC to 6th hour post CC

• 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)

  From pre-CC to 6th hour post CC

• Score and biomarkers performance for prediction

  From pre-CC to 6th hour post CC

• Algorithm

  From pre-CC to 6th hour post CC

• 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)

  beyond 48th hour post CC to 7 days

Interventions

Early biomarkers of acute kidney injury DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Roche Pharma AG: collaborator
• ThermoFisher Scientific Brahms Biomarkers France: collaborator

Study Sites (1)

Nantes UH

Nantes, 44000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Karim Lakhal, MD

  Nantes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 16, 2022
• Study Start: November 22, 2022
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)