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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine group | Experimental | 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. |
|
| Dopamine group | Experimental | 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. |
|
| Epinephrine group | Experimental | The initial dose is 0.02 μg/kg/min of epinephrine; each adjustment (increase or decrease) is 0.02 μg/kg/min of epinephrine; the maximum dose of epinephrine is 0.2 μg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality within 28 days | 28 days after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic parameters | Haemodynamic parameters at H0, H6, H24, H48 and H72 | |
| Severe arrhythmia (ventricular tachycardia, ventricular fibrillation) | Time of onset of severe arrhythmia | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Gu,MD | Contact | +86 010-88392814 | guqingfw@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Beijing | Beijing Municipality | 10037 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2025 | Jun 21, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2025 | Jun 21, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D004298 | Dopamine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Dopamine | Drug | 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 |
|
| Epinephrine | Drug | 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 |
|
| Adverse effects of vasopressors |
| Time at which adverse effects occur |
| Arterial Blood Gas Analysis | 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 | 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 | 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 | 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) |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510180 | China |
|
| Zhongnan Hospital of Wuhan University | Wuhan | Wuhan | 430072 | China |
|
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |