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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
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Le Plessis-Robinson、フランス、92350
- Hôpital Marie Lannelongue
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：ノルエピネフリン
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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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実験的：バソプレシン
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room.
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-525153-39-00
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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