- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07614438
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery, (VANOPE)
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery, a Randomized Open Label Trial
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Le Plessis-Robinson, Francia, 92350
- Hôpital Marie Lannelongue
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Noradrenalina
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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.
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Sperimentale: Vasopressina
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room.
Lasso di tempo: at the end of skin closure immediately following the completion of the PEA procedure.
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at the end of skin closure immediately following the completion of the PEA procedure.
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Malattie delle vie respiratorie
- Malattie polmonari
- Ipertensione
- Ipertensione, polmonare
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Ormoni peptidici
- Neuropeptidi
- Peptidi
- Aminoacidi, peptidi e proteine
- Oligopeptidi
- Proteine del tessuto nervoso
- Proteine
- Prodotti chimici organici
- Idrocarburi
- Idrocarburi, ciclici
- Idrocarburi, aromatici
- Ammine
- Cateco
- Fenoli
- Derivati di benzene
- Alcoli
- Aminouli
- Etanolamine
- Monoamine biogeniche
- Amine biogeniche
- Catecolamine
- Ormoni pituitari, posteriore
- Ormoni pituitari
- Noradrenalina
- Vasopressine
Altri numeri di identificazione dello studio
- 2025-525153-39-00
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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