Medical University Of Vienna
Verified
Vienna, Austria
Not recruiting
Study on the Effects of Epinephrine, Norepinephrine, and Phenylephrine on Heart Function During Major Abdominal Surgery
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on patients undergoing open major abdominal surgery. The study aims to understand the effects of three medications: epinephrine, norepinephrine, and phenylephrine on the heart's performance during surgery. These medications are used to support blood pressure and heart function. Epinephrine, also known as adrenaline, is a medication that can increase heart rate and blood flow. Norepinephrine, also called noradrenaline, helps to narrow blood vessels and increase blood pressure. Phenylephrine is another medication that can increase blood pressure by narrowing blood vessels.
The purpose of the study is to compare how these medications affect the heart's ability to pump blood during surgery. Participants will receive one of these medications through an intravenous infusion, which means the medication is given directly into a vein. The study is designed to be double-blinded, meaning neither the participants nor the researchers know which medication each participant is receiving, to ensure unbiased results. The study will also look at how these medications affect oxygen levels in the brain and other tissues during surgery.
Participants in the study will be monitored throughout their surgery to measure the heart's performance and oxygen levels. The study will help determine which medication provides the best support for patients undergoing major abdominal surgery. This information could improve the care and outcomes for patients in similar situations in the future.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
13 criteria
- Must be 45 years old or older.
- Scheduled for a moderate- to high-risk major open abdominal surgery that is expected to last at least 2 hours.
- Must have an ASA physical status of 2 or higher. (ASA physical status is a system used to assess the fitness of patients before surgery, with higher numbers indicating more health issues.)
- Must have at least one of the following risk factors:
- Age 75 years or older
- History of peripheral arterial disease (a condition affecting blood flow in the arteries)
- History of coronary artery disease (a condition affecting blood flow to the heart)
- History of stroke or transient ischemic attack (a temporary period of symptoms similar to those of a stroke)
- History of chronic kidney disease (long-term kidney damage)
- Diabetes that requires medical treatment
- Current smoking or a history of smoking at least 15 pack-years (a pack-year is smoking 20 cigarettes a day for one year)
- History of heart failure (a condition where the heart doesn't pump blood as well as it should)
- Preoperative high-sensitivity Troponin T level of 14 ng/L or higher (a blood test that measures heart muscle damage)
- Preoperative NT-proBNP level of 200 pg/mL or higher (a blood test that measures heart stress)
Who cannot join the trial?
3 criteria
- Patients who are not undergoing open major abdominal surgery cannot participate. This means the surgery involves a large incision in the belly area.
- Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
- Patients who are part of a vulnerable population cannot participate. This includes groups that may need special protection or care.
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Investigated drugs
Epinephrine
is a medication that helps to increase the heart rate and improve blood flow. It is often used in medical settings to help the heart work better, especially during surgery. In this trial, epinephrine is being studied to see how it affects the heart's performance during operations.
Norepinephrine
is a medication that is used to increase blood pressure and improve blood flow. It works by narrowing blood vessels, which helps to raise blood pressure. This medication is being tested in the trial to understand its impact on heart function during surgery.
Phenylephrine
is a medication that is used to increase blood pressure by tightening blood vessels. It is often used to help maintain stable blood pressure during surgery. In this trial, phenylephrine is being evaluated to see how it affects the heart's performance while a patient is undergoing an operation.
What is already known about the treatment
Epinephrine
Epinephrine is administered through continuous infusion during surgery to help manage blood flow and heart function. It is currently being studied in clinical trials to understand its effects on heart performance during major abdominal surgeries. This medication is primarily used to support heart function and blood pressure. At the molecular level, epinephrine works by stimulating receptors in the heart and blood vessels, leading to increased heart rate and blood pressure. It is classified as a sympathomimetic drug, which means it mimics the effects of the sympathetic nervous system.
Norepinephrine
Norepinephrine is given through continuous infusion to help maintain stable blood pressure and heart function during surgery. It is being evaluated in clinical trials for its impact on heart performance in patients undergoing major abdominal surgeries. The main use of norepinephrine is to support blood pressure and heart function. It acts by stimulating specific receptors in the heart and blood vessels, which increases blood pressure. Norepinephrine is also classified as a sympathomimetic drug.
Phenylephrine
Phenylephrine is administered via continuous infusion to help control blood pressure during surgical procedures. It is part of ongoing clinical trials to assess its effects on heart performance during major abdominal surgeries. This medication is mainly used to increase blood pressure. At the molecular level, phenylephrine works by stimulating receptors in the blood vessels, causing them to constrict and raise blood pressure. It is classified as a sympathomimetic drug.
Investigated diseases
Postoperative Complications – Postoperative complications refer to a range of issues that can occur after undergoing surgery. These complications can affect various systems in the body, including the cardiovascular, respiratory, and digestive systems. Common complications include infections, bleeding, and delayed healing of the surgical site. Cardiovascular complications may involve changes in heart rate or blood pressure, while respiratory issues can include difficulty breathing or reduced oxygen levels. The progression of these complications depends on the individual's health, the type of surgery performed, and the body's response to the surgical intervention. Monitoring and supportive care are essential to manage these complications effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517373-25-00Protocol codeRACE_01Estimated enrolment225 patientsSponsorMedical University Of Vienna
sourced from the EU Clinical Trials Register and site verification
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