Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Hypertension, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Conditions
Keywords
Hypertension, Pulmonary, Cardiovascular Diseases, Vascular Diseases, Dopamine, Norepinephrine, Epinephrine, Haemodynamic Monitoring, Efficacy and Safety, Chronic thromboembolic pulmonary hypertension, Heart Failure, Pulmonary circulation, Pulmonary Arterial Hypertension
Brief summary
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
Interventions
DRUGNorepinephrine
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.
DRUGDopamine
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
DRUGEpinephrine
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
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years old; 2. Signed informed consent form; 3. Confirmed diagnosis of arterial pulmonary hypertension (PAH) and/or chronic thromboembolic pulmonary hypertension (CTEPH); 4. Presenting with manifestations of pulmonary hypertensive crisis; 5. Receiving both diagnosis and treatment in-hospital; 6. No intravenous administration of the vasopressor drugs (including dopamine, norepinephrine, and epinephrine) under study at enrollment.
Exclusion criteria
1. At SCAI stage D or stage E ; 2. Patients who only receive a diagnosis but no treatment in the hospital; 3. Uncontrolled hyperthyroidism; 4. Complicated with angle-closure glaucoma; 5. Hypersensitivity to the study drug; 6. Ongoing use of halogenated hydrocarbon general anesthetics such as cyclopropane and halothane; 7. Ongoing use of monoamine oxidase inhibitor (MAOI) antidepressants or anti-Parkinson drugs (phenelzine, tranylcypromine, isocarboxazid, moclobemide); 8. Pregnancy; 9. Already receiving the vasopressor drugs (dopamine, norepinephrine, epinephrine) under study at enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 28 days | 28 days after enrolment |
Secondary
| Measure | 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 |
| 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) |
Countries
China
Contacts
CONTACTQing Gu,MD
Outcome results
None listed