Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
調査の概要
詳細な説明
Subjects enrolled in the retrospective study may be enrolled in a prospective study if the study drug is re-used, but in the end only the most-registered case of the subject would be collected.
The recommended treatment plan for this study is from the usage and dosage of NIF. The clinician can make appropriate adjustments to the specific usage and dosage according to the patient's condition.
Load dose: Adults usually use 0.3mg/kg each time, under continuous ECG monitoring, the injection should be completed within 5 minutes, and the maximum dose should not exceed 0.5 mg/kg.
Maintenance dose: After load injection, the adult routine dose is 0.4 mg/kg/h under continuous ECG monitoring. The dosage could be appropriately increased or decreased according to the patient's reaction, but the maximum dose should not exceed 0.8 mg/kg/h.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100000
- 募集
- Peking University First Hospital
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コンタクト：
- Jing Zhou
- 電話番号：+86-136 5118 5517
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
- Patients who have received or are about to receive Nifekalant Hydrochloride for treatment according to the instructions.
Exclusion Criteria:
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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
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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The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
時間枠：From the beginning of the administration to 48 hours after the end of the administration.
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The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
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From the beginning of the administration to 48 hours after the end of the administration.
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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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Number of Participants with adverse events
時間枠：From the beginning of the administration to 48 hours after the end of the administration.
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Number of Participants with Tdp, ventricular tachycardia or ventricular fibrillation.
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From the beginning of the administration to 48 hours after the end of the administration.
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Heart rate
時間枠：3 days before the beginning of the administration to 48 hours after the end of the administration.
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The subjects' heart rate will be recorded and the abnormalities will be analyzed.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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The survival rate
時間枠：30 days after the end of administration.
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The 30 days survival rate.
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30 days after the end of administration.
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Blood pressure
時間枠：3 days before the beginning of the administration to 48 hours after the end of the administration.
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Both systolic and diastolic pressures will be assessed during the study period.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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Respiratory rate
時間枠：3 days before the beginning of the administration to 48 hours after the end of the administration.
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The respiratory status of all subjects will be recorded the incidence of abnormalities will be calculated.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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Body temperature
時間枠：3 days before the beginning of the administration to 48 hours after the end of the administration.
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The subjects' temperatures will be recorded and the abnormalities will be analyzed.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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協力者と研究者
捜査官
- 主任研究者：Jing Zhou、Peking University First Hospital
- 主任研究者：Min Yi Cui、Peking University First Hospital
- 主任研究者：Xin Hu、Beijing Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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。