ARGIPRESSIN for Chronic thromboembolic pulmonary hypertension

Inclusion criteria

• {"criterion_text":"-Age ≥18 years;\n-Patient scheduled for pulmonary endarterectomy surgery;\n-In women of childbearing potential: negative serum pregnancy test and use of adequate contraception;\n-Affiliation to the French social care service;\n-Patient able to understand and sign a written informed consent form."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"-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","definition_or_measurement_approach":"Measured by the Swan-Ganz catheter in the operating room, specifically recorded at the end of skin closure immediately after completion of the PEA procedure."}

Secondary endpoints

• {"endpoint_text":"-mPAP (mmHg) measured by the Swan-Ganz catheter -\tVascular pulmonary resistance (in wood unit) measured by the Swan-Ganz catheter;","definition_or_measurement_approach":"mPAP measured by Swan-Ganz catheter; vascular pulmonary resistance measured by Swan-Ganz catheter."}
• {"endpoint_text":"-Vascular pulmonary resistance (in wood unit) measured by the Swan-Ganz catheter;","definition_or_measurement_approach":"Vascular pulmonary resistance measured by Swan-Ganz catheter."}
• {"endpoint_text":"-Cardiac output (in liter per minute, l/min) measured by the Swan-Ganz catheter;","definition_or_measurement_approach":"Cardiac output measured by Swan-Ganz catheter (L/min)."}
• {"endpoint_text":"-Pulmonary artery compliance measured by the Swan Ganz catheter;","definition_or_measurement_approach":"Pulmonary artery compliance measured by Swan-Ganz catheter."}
• {"endpoint_text":"-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;","definition_or_measurement_approach":"Defined as need for inotropic support and/or mechanical circulatory assistance (veno-venous or veno-arterial ECMO) for weaning from cardiopulmonary bypass (CPB)."}
• {"endpoint_text":"-Defined according to KDIGO classification or the need for renal replacement therapy;","definition_or_measurement_approach":"Acute kidney injury defined according to KDIGO classification or requirement for renal replacement therapy."}
• {"endpoint_text":"-Defined by at least one documented episode of atrial fibrillation or atrial flutter;","definition_or_measurement_approach":"Occurrence of at least one documented episode of atrial fibrillation or atrial flutter."}
• {"endpoint_text":"-Defined by any airway hemorrhage with at least one local treatment: local application of vasoactive substance, bronchial exclusion, embolization, or salvage surgery;","definition_or_measurement_approach":"Airway hemorrhage requiring at least one local therapeutic intervention (e.g., topical vasoactive application, bronchial exclusion, embolization, or salvage surgery)."}
• {"endpoint_text":"-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);","definition_or_measurement_approach":"Composite respiratory outcome including failure to wean from invasive ventilation and sedatives within 24h, need for neuromuscular blockers, inhaled NO, prone positioning, pneumonia, ICU readmission for acute respiratory failure, or need for respiratory support (noninvasive or invasive)."}
• {"endpoint_text":"-Defined as an acute coronary syndrome during the hospital stay;","definition_or_measurement_approach":"Occurrence of acute coronary syndrome during the hospital stay."}
• {"endpoint_text":"-Defined as mesenteric or colonic ischemia confirmed by imaging or endoscopy;","definition_or_measurement_approach":"Mesenteric or colonic ischemia confirmed by imaging (CT) or endoscopy."}
• {"endpoint_text":"-Defined as acute stroke (ischemic or hemorrhagic), confusion, or seizures;","definition_or_measurement_approach":"Neurological complications defined as acute ischemic or hemorrhagic stroke confirmed by imaging, postoperative confusion (CAM-ICU), or clinically/EEG documented seizures."}
• {"endpoint_text":"-Defined as the occurrence of surgical site infection according to the CDC definition;","definition_or_measurement_approach":"Surgical site infection as defined by CDC criteria."}
• {"endpoint_text":"-Defined as any surgical reintervention of the surgical site during the first 30 days following surgery;","definition_or_measurement_approach":"Any surgical reintervention at the surgical site within 30 days post-surgery."}
• {"endpoint_text":"-Calculated in days, from the time of admission (to ICU and hospital) until the time of discharge (from ICU and hospital) whatever the cause;","definition_or_measurement_approach":"Length of stay in ICU and hospital calculated in days from admission to discharge."}
• {"endpoint_text":"-All-cause mortality.","definition_or_measurement_approach":"All-cause mortality (including in-hospital and at 30 days)."}

France

Earliest CTIS Part Ii Submission Date

16-04-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

26

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

Fondation Hopital Saint Joseph

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France