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

NCT07614438 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-29

No results posted yet for this study

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.

We 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.

Conditions

  • Anesthesia
  • Pulmonary Hypertension
  • Chronic Pulmonary Thromboembolism
  • Vasopressor

Interventions

DRUG

Vasopressin

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.

DRUG

Norepinephrine

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.

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-08-02
Completion
2028-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614438 on ClinicalTrials.gov