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

Sponsor
Fondation Hôpital Saint-Joseph
Study ID
NCT07614438
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anesthesia
  • Chronic Pulmonary Thromboembolism
  • Pulmonary Hypertension
  • Vasopressor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Aug 2, 2026
Completion
Sep 1, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vasopressin
  • Active Comparator: Norepinephrine

Primary Outcome Measure

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. ]

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