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

NCT05283213 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-01-26

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • ThermoFisher Scientific Brahms Biomarkers France

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Karim Lakhal, MD · Nantes UH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2025-03-10
Completion
2025-03-10

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283213 on ClinicalTrials.gov