Effect of vasopressin versus norepinephrine on post-operative mean pulmonary arterial pressure following pulmonary endarterectomy surgery, a randomized open label trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondation Hopital Saint Joseph

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Cardiovascular Diseases [C14], Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Decision date (initial)

2026-05-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

French Ministry of Health

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the efficacy of vasopressin versus norepinephrine on the immediate post-operative reduction in mean pulmonary arterial pressure (mPAP) following pulmonary artery endarterectomy.

Secondary objectives 16

1. To compare the mPAP over time at CPB weaning, ICU admission and Swan-Ganz catheter removal;
2. To compare the vascular pulmonary resistance over time at CPB weaning, ICU admission and Swan-Ganz catheter removal;
3. To compare the cardiac output over time at CPB weaning, ICU admission and Swan-Ganz catheter removal
4. To compare the pulmonary artery compliance over time at CPB weaning, ICU admission and Swan-Ganz catheter removal;
5. To compare the incidence of CPB weaning failure;
6. To compare the incidence of acute kidney injury or the need for renal replacement therapy;
7. To compare the incidence of supraventricular arrhythmia;
8. To compare the incidence of airway hemorrhage requiring therapeutic intervention
9. To compare the incidence of major pulmonary complications;
10. To compare the incidence of major cardiac complications;
11. To compare the incidence of major gastrointestinal complications;
12. To compare the incidence of major neurological complications;
13. To compare the incidence of surgical site infection;
14. To compare the incidence of surgical reintervention;
15. To compare the duration of ICU and hospital length of stay;
16. To compare the 30 days all-cause mortality rate.

Conditions and MedDRA coding

Chronic thromboembolic pulmonary hypertension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥18 years;
2. Patient scheduled for pulmonary endarterectomy surgery;
3. In women of childbearing potential: negative serum pregnancy test and use of adequate contraception;
4. Affiliation to the French social care service;
5. Patient able to understand and sign a written informed consent form.

Exclusion criteria 9

1. Emergency surgery;
2. Mesenteric ischemia and/or acute coronary syndrome within the month preceding the intervention;
3. Known allergy to the active substance vasopressin or to any of its excipients;
4. Concomitant coronary bypass procedure or other combined surgery (i.e. valve replacement);
5. mPAP<25 mmHg on preoperative right heart catheterization;
6. Patient participating to another interventional clinical trial;
7. For females only: documented pregnancy or lactation;
8. Patient under tutorship, curatorship or legal protection
9. Patient deprived of liberty.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room, specifically recorded at the end of skin closure immediately following the completion of the PEA procedure

Secondary endpoints 16

1. mPAP (mmHg) measured by the Swan-Ganz catheter - Vascular pulmonary resistance (in wood unit) measured by the Swan-Ganz catheter;
2. Vascular pulmonary resistance (in wood unit) measured by the Swan-Ganz catheter;
3. Cardiac output (in liter per minute, l/min) measured by the Swan-Ganz catheter;
4. Pulmonary artery compliance measured by the Swan Ganz catheter;
5. Defined as the necessity for inotropic support and/or mechanical circulatory assistance, i.e., veno-venous or veno-arterial extracorporeal membrane oxygenation (ECMO) for weaning CPB;
6. Defined according to KDIGO classification or the need for renal replacement therapy;
7. Defined by at least one documented episode of atrial fibrillation or atrial flutter;
8. Defined by any airway hemorrhage with at least one local treatment: local application of vasoactive substance, bronchial exclusion, embolization, or salvage surgery;
9. Defined by the occurrence of at least (composite outcome): failure to wean off invasive mechanical ventilation and sedatives, need for neuromuscular blockers, inhaled NO, prone positioning, pneumonia, ICU readmission for acute respiratory failure or need for respiratory support (noninvasive or invasive ventilation);
10. Defined as an acute coronary syndrome during the hospital stay;
11. Defined as mesenteric or colonic ischemia confirmed by imaging or endoscopy;
12. Defined as acute stroke (ischemic or hemorrhagic), confusion, or seizures;
13. Defined as the occurrence of surgical site infection according to the CDC definition;
14. Defined as any surgical reintervention of the surgical site during the first 30 days following surgery;
15. Calculated in days, from the time of admission (to ICU and hospital) until the time of discharge (from ICU and hospital) whatever the cause;
16. All-cause mortality.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondation Hopital Saint Joseph

Sponsor organisation

Fondation Hopital Saint Joseph

Address

133 Avenue De La Resistance

City

Le Plessis-Robinson

Postcode

92350

Country

France

Scientific contact point

Organisation

Fondation Hopital Saint Joseph

Contact name

Dr. Sylvain DIOP

Public contact point

Organisation

Fondation Hopital Saint Joseph

Contact name

Delphine Chevalier

Sponsor responsibilities

Article 77 implementation

Fondation Hopital Saint Joseph

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications