Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery,

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.

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Key information

Conditions

Anesthesia Cardiovascular Diseases Chronic Pulmonary Thromboembolism Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases Vasopressor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vasopressin

Drug

After inclusion and randomization, the intervention group will receive Vasopressin at a concentration of 0.04 IU/mL by continuous infusion (from 10 ml/h to 50 ml/h, by step of 3 ml/h) to target a MAP > 65 mmHg according to the protocol Vasopressin is continued for the first 24 hours in the intensive care unit following the same protocol.

norepinephrine

Drug

After inclusion and randomization, the control group will receive norepinephrine at a concentration of 16 μg/mL by continuous infusion (from 10 ml/h to 50 ml/h, by step of 3 ml/h) to target a MAP > 65 mmHg according to the protocol. Norepinephrine is continued for the first 24 hours in the intensive care unit following the same protocol.

Primary outcomes

mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room.

Time frame: at the end of skin closure immediately following the completion of the PEA procedure.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery, a Randomized Open Label Trial

Acronym: VANOPE

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2028
First posted: May 29, 2026
Registry last updated: Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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