Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
調査の概要
詳細な説明
Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.
Phase 2 - All remaining subjects received Iloprost as a continuous treatment.
The study was designed for an enrollment of 200 subjects and was ended early.
研究の種類
入学 (実際)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
- Indwelling arterial catheter.
- Signed informed consent
Exclusion Criteria:
- Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
- Known hypersensitivity to prostacyclin compounds
- Patients receiving sildenafil or bosentan
- Refusal by the attending physician
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：非ランダム化
- 介入モデル：クロスオーバー割り当て
- 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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実験的：Phase 2: Inhaled Iloprost continuous
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. |
A 20 mcg dose of Iloprost will be given initially.
他の名前：
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実験的：Phase 1: Inhaled Iloprost 3 doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. |
A 20 mcg dose of Iloprost will be given initially.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
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Percent Change in Oxygen Saturation (SpO2) From Baseline
時間枠：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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Readings were taken from the medical record and the data may not have been present at the exact time frames.
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30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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Percent Change in Oxygen Saturation (SpO2) From Baseline
時間枠：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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Change in Mean Heart Rate From Baseline
時間枠：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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Change in Mean Heart Rate From Baseline
時間枠：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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Number of Treatment Failures
時間枠：as long as subject was on drug up to approximately 24 hours
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Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:
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as long as subject was on drug up to approximately 24 hours
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Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
時間枠：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
時間枠：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Cardiac Output (CO) From Baseline
時間枠：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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Change in Cardiac Output (CO) From Baseline
時間枠：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
時間枠：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
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30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
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Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
時間枠：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Neil MacIntyre, MD、Duke University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。