Vasopressor Agents in Pulmonary Hypertension Crisis

Официальное название

Comparison of the Efficacy and Safety of Dopamine, Norepinephrine and Epinephrine in the Treatment of Pulmonary Hypertensive Crisis Under Hemodynamic Monitoring

Обзор

Comparison of the efficacy and safety of three vasoactive agents-dopamine, norepinephrine, and epinephrine-in the treatment of patients with pulmonary hypertension crisis: prospective, randomised controlled trial monitored by haemodynamic monitoring

Вмешательства

• Препарат Norepinephrine
  The initial dose is 0.02 mg/kg/min of norepinephrine; each dose adjustment (increase or decrease) is 0.02 mg/kg/min of norepinephrine; the maximum dose of norepinephrine is 0.2 mg/kg/min.
• Препарат Dopamine
  The initial dose is 2 μg/kg/min of dopamine; each dose adjustment (increase or decrease) is 2 μg/kg/min of dopamine; the maximum dose of dopamine is 20 μg/kg/min
• Препарат Epinephrine
  The initial dose is 0.02 μg/kg/min of epinephrine; each adjustment (up or down) is 0.02 μg/kg/min of epinephrine; the maximum dose of epinephrine is 0.2 μg/kg/min

Первичные конечные точки

• All-cause mortality within 28 days [Срок оценки: 28 days after enrolment]

Вторичные конечные точки (7)

• Haemodynamic parameters [Срок оценки: Haemodynamic parameters at H0, H6, H24, H48 and H72]
• Severe arrhythmia (ventricular tachycardia, ventricular fibrillation) [Срок оценки: Time of onset of severe arrhythmia]
• Adverse effects of vasopressors [Срок оценки: Time at which adverse effects occur]
• Arterial Blood Gas Analysis [Срок оценки: H0, H6, H24, H48, H72, Day 7, Day 14, Day 21, Day 28 (if the length of hospital stay is between 7 and 28 days, a test must be performed on the day of discharge)]
• Vital Signs [Срок оценки: Record at H0, H2, H4, H6, H12, H24, H48 and H72 after administration of medication; thereafter, record once every 24 hours until the day of discharge]
• BNP or NT-proBNP [Срок оценки: H0, H24, H48, H72, Day 7, Day 14, Day 21, Day 28 (if the length of hospital stay is between 7 and 28 days, a test must be performed on the day of discharge)]
• Echocardiographic parameters [Срок оценки: H0, H24, H48, H72, Day 7, Day 14, Day 21, Day 28 (if the length of hospital stay is between 7 and 28 days, a measurement must be taken on the day of discharge)]

Критерии участия

Критерии включения

• Age > 18 years old;
• Signed informed consent form;
• Confirmed diagnosis of arterial pulmonary hypertension (PAH) and/or chronic thromboembolic pulmonary hypertension (CTEPH);
• Presenting with manifestations of pulmonary hypertensive crisis;
• Receiving both diagnosis and treatment in-hospital;
• No intravenous administration of the vasopressor drugs (including dopamine, norepinephrine, and epinephrine) under study at enrollment.

Критерии исключения

• At SCAI stage D or stage E ;
• Patients who only receive a diagnosis but no treatment in the hospital;
• Uncontrolled hyperthyroidism;
• Complicated with angle-closure glaucoma;
• Hypersensitivity to the study drug;
• Ongoing use of halogenated hydrocarbon general anesthetics such as cyclopropane and halothane;
• Ongoing use of monoamine oxidase inhibitor (MAOI) antidepressants or anti-Parkinson drugs (phenelzine, tranylcypromine, isocarboxazid, moclobemide);
• Pregnancy;
• Already receiving the vasopressor drugs (dopamine, norepinephrine, epinephrine) under study at enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Chinese Academy of Medical Sciences, Fuwai Hospital — Пекин
• Guangdong Provincial People's Hospital — Гуанчжоу
• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT07667829 · 2024ZD0526703

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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