NCT05283213

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-22
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2022-03-16
• Last updated: 2026-01-26

Locations

1 site across 1 country: France