NCT07614438Not yet recruitingPhase 2
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery,
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery, a Randomized Open Label Trial
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 22 May 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 2 Aug 2026
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- NCT number
- NCT07614438
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 1 Aug 2026 to the primary completion date, 2 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery;
- Preoperative administration of norepinephrine and/or inotropic drugs (dobutamine, isoproterenol, epinephrine) or patients assisted by veno-venous or veno-arterial ECMO before surgery;
- Concomitant coronary bypass procedure or other combined surgery (i.e. valve replacement);
Other illness
- Mesenteric ischemia and/or acute coronary syndrome within the month preceding the intervention;
- Known allergy to the active substance vasopressin or to any of its excipients;
- mPAP\<25 mmHg on preoperative right heart catheterization;
Other
- Patients with documented mesenteric artery stenosis;
- Impossibility to insert the pulmonary artery catheter (anatomical or technical issue);
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Marie Lannelongue Coordinator of this site? Confirm its status | Le Plessis-Robinson | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.