Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Fo… (NCT07614438) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery,
France90 participantsStarted 2026-08-01
Plain-language summary
Chronic thromboembolic pulmonary hypertension (CTEPH), one of the leading causes of pulmonary hypertension (PH), is caused by the chronic obstruction of the pulmonary arteries following episode of pulmonary embolism. It is the only cause of PH which is accessible to a potential curative surgical treatment: the pulmonary endarterectomy (PEA). Because of their underlying disease (pulmonary hypertension and potential right heart dysfunction), anesthesia should be performed cautiously. Perioperative hemodynamic management often requires the administration of a vasopressor to maintain the arterial pressure above a specific threshold of 65 mmHg.
Low dose of vasopressin increases systemic arterial pressure with minimal effects on the pulmonary circulation. This profile suggests that vasopressin may be an ideal agent for vasopressor support in the high-risk population of patients with pulmonary hypertension.
To date, there is no data on the use of vasopressin in patient undergoing PEA surgery. The interesting properties of vasopressin - specifically, its ability to increase systemic arterial resistance while having a low impact on pulmonary resistance and offering potential renal protective effects - are highly advantageous in the specific subset of patient scheduled for PEA.
The investigators aim to conduct a randomized single center open label study to compare the effect of vasopressin compared to norepinephrine on mean pulmonary artery pressure after PEA surgery.
The primary objective of this study is to determine whether the use of vasopressin compared to norepinephrine decrease the mean pulmonary artery pressure after PEA surgery.
Participation to the study involves follow up at day 30 following surgery.
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;
* Patient scheduled for pulmonary endarterectomy surgery;
* In women of childbearing potential: negative serum pregnancy test and use of adequate contraception;
* Affiliation to the French social care service;
* Patient able to understand and sign a written informed consent form.
Exclusion Criteria:
* Emergency surgery;
* Mesenteric ischemia and/or acute coronary syndrome within the month preceding the intervention;
* Patients with documented mesenteric artery stenosis;
* Impossibility to insert the pulmonary artery catheter (anatomical or technical issue);
* Preoperative administration of norepinephrine and/or inotropic drugs (dobutamine, isoproterenol, epinephrine) or patients assisted by veno-venous or veno-arterial ECMO before surgery;
* Known allergy to the active substance vasopressin or to any of its excipients;
* Concomitant coronary bypass procedure or other combined surgery (i.e. valve replacement);
* mPAP\<25 mmHg on preoperative right heart catheterization;
* Patient with preoperative natremia below 130 mol/L;
* Patient participating to another interventional clinical trial;
* For females only: documented pregnancy or lactation;
* Patient under tutorship, curatorship or legal protection;
* Patient deprived of liberty.
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.
What they're measuring
1
mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room.
Timeframe: at the end of skin closure immediately following the completion of the PEA procedure.