Study Comparing Vasopressin and Noradrenaline for Patients with Vasoplegic Syndrome Undergoing Cardiac Surgery with Extracorporeal Circulation

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What is this study about?

This clinical trial is focused on studying a condition known as vasoplegic syndrome, which can occur in patients undergoing heart surgery with the help of a machine that temporarily takes over the function of the heart and lungs, known as extracorporeal circulation. The study aims to compare two different treatments to manage blood pressure in these patients: Vasopressin and Norepinephrine. Vasopressin, also known by its code name REVERPLEG, is a medication that helps to increase blood pressure by narrowing blood vessels. Norepinephrine, also known as Noradrenaline, works similarly by tightening blood vessels to raise blood pressure.

The purpose of this study is to determine which of these two medications is more effective in preventing kidney problems and death within seven days after the onset of vasoplegic syndrome in patients undergoing heart surgery. Participants in the study will receive either Vasopressin or Norepinephrine through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

The study will monitor participants for any kidney complications or other health issues for up to 90 days after the onset of vasoplegic syndrome. This includes checking for heart problems, digestive issues, and brain-related complications. The study will also look at the overall costs and effectiveness of the treatments, including how long patients stay in the hospital and the costs associated with their care. The goal is to find the best strategy to manage blood pressure and improve outcomes for patients at risk of kidney problems during heart surgery.

1 joining the study

Upon joining the study, you will be required to provide written and informed consent. This confirms your understanding and agreement to participate in the trial.

2 preparation for surgery

You will undergo cardiac surgery that involves the use of a heart-lung machine, known as extracorporeal circulation. This surgery may include procedures like coronary bypass or valve repair.

3 treatment administration

During the trial, you will receive one of two medications: vasopressin or noradrenaline. These medications are administered through an intravenous infusion, which means they are delivered directly into your bloodstream.

The purpose of these medications is to help manage blood pressure during and after your surgery.

4 monitoring and follow-up

Your health will be closely monitored for any signs of kidney complications or other health issues for up to 7 days after the onset of vasoplegic syndrome, a condition that can occur after surgery.

Further follow-ups will occur at 30 and 90 days to check for any additional complications or health changes.

5 completion of the trial

The trial will conclude after the final follow-up at 90 days. Your participation will help in understanding the effectiveness of the medications in managing blood pressure and reducing complications after cardiac surgery.

Who Can Join the Study?

Patient who has given free, written, and informed consent.
Patient of legal age.
Patient requiring cardiac surgery (heart surgery) that is:
- Scheduled more than 24 hours in advance.
- Involving extracorporeal circulation (ECC), which means using a machine to take over the function of the heart and lungs during surgery.
- For procedures like myocardial revascularization (coronary bypass), surgical correction of valvulopathy (issues with heart valves such as aortic, mitral, pulmonary, or tricuspid), surgery on the ascending aorta, removal of an intracardiac tumor (a tumor inside the heart), or closure of a PFO/ASD (holes in the heart).
Patient with at least 3 risk factors for acute kidney failure (sudden kidney problems), including:
- Age over 70 years.
- Combined surgery (more than two procedures).
- Common trunk lesion (a problem in a major heart artery).
- Preoperative anemia (low red blood cell count before surgery).
- Chronic respiratory failure (long-term breathing problems).
- Obliterative arterial disease of the lower extremities (blocked arteries in the legs).
- Diabetes.
- Glomerular filtration rate less than 60 ml/min (a measure of kidney function).
- LVEF less than 40% (a measure of how well the heart pumps blood).
- Redux (repeat surgery).
- Intra-aortic counterpulsation balloon (a device to help the heart pump blood).
- Expected duration of bypass surgery more than 100 minutes.
- Albuminuria (protein in urine).
Negative pregnancy test for women of childbearing age.

Who Cannot Join the Study?

Patients who do not have vasoplegic syndrome cannot participate. Vasoplegic syndrome is a condition that can occur after heart surgery, where blood vessels become too relaxed, leading to low blood pressure.
Patients who are not undergoing cardiac surgery with extracorporeal circulation cannot participate. This type of surgery involves using a machine to take over the function of the heart and lungs during the operation.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Clinique De La Sauvegarde	Lyon	France
Clcjyn Hzhtveanmhh Utxngozsiouzc Aoqksf Paavybsz	Amiens	France
Cyrz Dl Npjwu	Vandoeuvre Les Nancy	France
Crrztj Htadyaidkip Uzhfzjoyiewpd De Dkfxs	Dijon	France
Bhzkaxro Uvpjzepyzd Hbeylyag Cknvmy	Besançon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.10.2022

Trial locations

Investigated drugs:

Vasopressin is a medication used in this clinical trial to help manage blood pressure in patients undergoing heart surgery. It works by narrowing blood vessels, which helps increase blood pressure. This is important during surgery because maintaining stable blood pressure can reduce the risk of complications, such as kidney problems or even death, especially in patients who are at risk of low blood pressure.

Norepinephrine is another medication being tested in this trial for its ability to manage blood pressure during heart surgery. Like vasopressin, norepinephrine helps to increase blood pressure by tightening blood vessels. This can be crucial for patients who might experience dangerously low blood pressure during surgery, as it helps ensure that vital organs, like the kidneys, receive enough blood and oxygen, potentially reducing the risk of complications.

Vasoplegic Syndrome – Vasoplegic syndrome is a condition characterized by severe low blood pressure due to the inability of blood vessels to constrict properly. It often occurs after cardiac surgery involving extracorporeal circulation. The syndrome leads to widespread dilation of blood vessels, resulting in inadequate blood flow to organs. This can cause complications such as acute kidney failure and may require interventions to stabilize blood pressure. The condition can also lead to cardiac complications like arrhythmias and myocardial damage. Additionally, it may cause digestive and cerebral complications, including ischemia and stroke.

Trial ID:

2022-500419-38-00

NCT ID:

NCT05568160

Trial Phase:

Therapeutic confirmatory (Phase III)

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