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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Effect of vasopressin versus norepinephrine on post-operative mean pulmonary arterial pressure following pulmonary endarterectomy surgery, a randomized open label trial

This study is looking at people who have a special lung operation called a pulmonary endarterectomy for a condition where blood clots cause high blood pressure in their lungs. Doctors are comparing two different medicines, vasopressin and norepinephrine, which are given through a drip after the surgery. The main aim is to see how well each medicine helps to lower the pressure in the lung arteries right after the operation. They will also look at how these medicines affect other things like how well the heart pumps and how long people stay in hospital.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Fondation Hopital Saint Joseph
Enrolment target
90
Start
12 May 2026

What is this study about?

This study is called a 'clinical trial', which is a careful way for doctors to test new treatments or compare existing ones. In this case, they are looking at a specific condition called chronic thromboembolic pulmonary hypertension. This is where old blood clots make the blood pressure in the lungs too high, which can make it hard to breathe and put a strain on the heart. The main treatment for this is an operation called a pulmonary endarterectomy (PEA) to remove these clots.

After this important surgery, it's really important to keep the blood pressure in the lung arteries at a healthy level. Doctors often use medicines given through a drip to help with this. This study is comparing two well-known medicines, vasopressin and norepinephrine, to see which one works better to lower this pressure right after the operation. By doing this, they hope to find the best way to help patients recover smoothly and reduce risks.

Measuring the pressure in the lung arteries is the main focus immediately after surgery. But the study also looks at many other important things, like how well the heart is working, whether kidneys or other organs are affected, and how quickly patients recover and leave the hospital. This detailed information will help doctors understand the full effects of each medicine and improve care for people having this operation in the future.

Key takeaways

  • Compares two existing medicines (vasopressin vs. norepinephrine) after lung surgery for high lung pressure.
  • Aims to find out which medicine better lowers lung pressure right after the operation.
  • Looks at many aspects of recovery, including heart function and hospital stay.
  • Participation involves receiving one of the medicines and close monitoring during your hospital stay.
  • Findings could help improve care for patients undergoing this specific lung surgery.

Who may be eligible?

To be able to take part in this study, you would need to be at least 18 years old. Both men and women can join.

The most important thing is that you have been diagnosed with chronic thromboembolic pulmonary hypertension and are planning to have the pulmonary endarterectomy surgery. Your doctors will carefully check your medical history to make sure the study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with chronic thromboembolic pulmonary hypertension?
  3. Are you scheduled to have pulmonary endarterectomy (PEA) surgery?
  4. Are you able to understand and provide consent for the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either vasopressin or norepinephrine through a drip immediately after your lung surgery. Which medicine you get will be decided by chance, like flipping a coin. Doctors will then closely watch your blood pressure in your lungs using a special thin tube, called a Swan-Ganz catheter, which is already in place for your surgery. They will take these measurements right after your operation, once your skin is stitched up.

Beyond this main measurement, the medical team will keep a close eye on many other aspects of your recovery, including your heart function, kidney health, and any other health issues that might come up while you are in the hospital. They will also record how long you stay in intensive care and in the hospital overall. All of these observations are part of your routine care after such an operation, but in the study, they are also carefully recorded for research purposes. The total duration of your active participation will be during your hospital stay.

Potential risks and benefits

Participating in this study might help doctors learn which medicine is better for managing lung pressure after surgery, which could improve care for future patients. For you, there's a chance that the medicine you receive could lead to a better recovery compared to the other. Both medicines are already used in hospitals, so doctors are familiar with them. However, like all medicines and medical procedures, there are potential risks and side effects, and your doctors will explain these to you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is chronic thromboembolic pulmonary hypertension?

It's a type of high blood pressure in the lungs caused by old blood clots that didn't go away.

What is a pulmonary endarterectomy (PEA)?

It's an operation to remove old blood clots from the lung arteries to lower the pressure.

Are the medicines in the study new?

No, both vasopressin and norepinephrine are existing medicines already used in hospitals.

What is a Swan-Ganz catheter?

It's a thin tube doctors use to measure pressures and blood flow in your heart and lungs during and after surgery.

Can I choose which medicine I get?

No, in this type of study, which medicine you receive is decided by chance to make the comparison fair.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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