Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study (NCT04062786) | Clinical Trial Compass
UnknownNot Applicable
Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study
France130 participantsStarted 2019-02-21
Plain-language summary
Acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation.
It is an independent risk factor for mortality and significantly increases the length of hospital stay.
The origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...).
Nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. This is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. Based on Guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the Pmsf-PVC gradient.
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:
* age\> 18 years
* subject having signed an informed consent
* scheduled heart surgery:
* Valve replacement
* Coronary artery bypass
Exclusion Criteria:
* Any urgent surgery or redux
* Severe preoperative chronic renal failure (stage III) defined by GFR \<30ml / min
* Existence of rhythm disorders (permanent ACFA) or serious cardiac conduction disorders, patients with Pacemaker
* Preoperative alteration of left ventricular ejection fraction with LVEF \<40%
* Major haemodynamic instability with refractory shock defined by dobutamine ≥10μg / kg / min and / or norepinephrine ≥ 1μg / kg / min and / or epinephrine ≥ 0.2μg / kg / min.
* Intra-aortic versus assisted pelvic balloon
* Contraindication to femoral arterial catheterization
* Subject under the protection of justice, subject under guardianship or under tutorship
* Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)
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.