Development of an Innovative Clinico-biological Score for the Early Detection of Acute Renal Fail… (NCT05283213) | Clinical Trial Compass
CompletedNot Applicable
Development of an Innovative Clinico-biological Score for the Early Detection of Acute Renal Failure Associated With Cardiac Surgery.
France400 participantsStarted 2022-11-22
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.