Ongoing Clinical Trials for Vasoplegia Syndrome
There is currently 1 ongoing clinical trial investigating treatments for vasoplegia syndrome, a serious condition that can occur after heart surgery where blood vessels become too relaxed, leading to dangerously low blood pressure. This trial is comparing two medications used to manage blood pressure in patients undergoing cardiac surgery with extracorporeal circulation.
Clinical trial locations
Study Comparing Vasopressin and Noradrenaline for Patients with Vasoplegic Syndrome Undergoing Cardiac Surgery with Extracorporeal Circulation
This clinical trial is investigating vasoplegia syndrome, a condition where blood vessels become overly relaxed, causing severe low blood pressure in patients undergoing heart surgery with the help of a heart-lung machine. The study is taking place in France and aims to find the best way to manage blood pressure during and after cardiac surgery.
Main inclusion criteria:
- Adults requiring scheduled cardiac surgery with extracorporeal circulation, such as coronary bypass, valve repair or replacement, surgery on the ascending aorta, removal of heart tumors, or closure of heart defects
- Patients with at least 3 risk factors for acute kidney failure, which may include being over 70 years old, having combined surgery procedures, diabetes, chronic breathing problems, reduced kidney function, weakened heart function, or previous heart surgery
- Able to provide written informed consent
- Women of childbearing age must have a negative pregnancy test
Main exclusion criteria:
- Patients who do not develop vasoplegia syndrome
- Those not undergoing cardiac surgery with a heart-lung machine
- Patients outside the specified age range
- Vulnerable populations who may have limited ability to give informed consent or are at higher risk of harm
Focus and goals:
The trial aims to compare two medications for managing blood pressure in patients at risk of vasoplegia syndrome during cardiac surgery. The primary goal is to determine which treatment is more effective in preventing kidney problems and death within seven days after the syndrome begins. Researchers will also monitor participants for heart problems, digestive issues, and brain-related complications for up to 90 days. The study will evaluate the overall costs and effectiveness of each treatment approach, including hospital stay duration and associated care costs.
Investigational drugs:
The trial is testing vasopressin and norepinephrine (also called noradrenaline), both administered through intravenous infusion directly into the bloodstream. Both medications work by narrowing blood vessels to increase blood pressure, which is crucial for maintaining adequate blood flow to vital organs like the kidneys during surgery. Vasopressin binds to receptors in blood vessels causing them to constrict, while norepinephrine stimulates receptors in both the heart and blood vessels, increasing heart rate and causing blood vessel constriction. Both are classified as vasopressors, medications specifically used to raise blood pressure.
Participants will be closely monitored throughout their surgery and recovery. After joining the study and undergoing cardiac surgery, patients will receive one of the two medications to help manage their blood pressure. Health monitoring will focus on kidney complications and other health issues for 7 days after the onset of vasoplegia syndrome, with additional follow-up visits at 30 and 90 days to check for any complications or health changes.
Summary
Currently, only one clinical trial is actively recruiting patients with vasoplegia syndrome, and it is being conducted in France. This trial focuses specifically on patients undergoing cardiac surgery with extracorporeal circulation who are at high risk for kidney complications. The study compares two vasopressor medications, vasopressin and norepinephrine, both of which work to increase blood pressure by constricting blood vessels. The trial’s emphasis on preventing kidney failure and reducing mortality within the critical first seven days after surgery highlights the serious nature of vasoplegia syndrome and the urgent need for effective treatment strategies. The comprehensive follow-up period of 90 days allows researchers to assess not only immediate outcomes but also longer-term complications and overall effectiveness of each treatment approach.
