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Not yet recruiting NCT07667829

Vasopressor Agents in Pulmonary Hypertension Crisis

No phase Interventional Pulmonary Arterial Hypertension (PAH) Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Hypertension, Pulmonary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norepinephrine, Dopamine, Epinephrine.
Who it may be relevant to
Registry conditions: Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Hypertension, Pulmonary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug 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.
  • Drug 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
  • Drug 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

Primary outcome measures

  • All-cause mortality within 28 days [Time frame: 28 days after enrolment]
Secondary outcome measures (7)
  • Haemodynamic parameters [Time frame: Haemodynamic parameters at H0, H6, H24, H48 and H72]
  • Severe arrhythmia (ventricular tachycardia, ventricular fibrillation) [Time frame: Time of onset of severe arrhythmia]
  • Adverse effects of vasopressors [Time frame: Time at which adverse effects occur]
  • Arterial Blood Gas Analysis [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing
  • Guangdong Provincial People's Hospital — Guangzhou
  • Zhongnan Hospital of Wuhan University — Wuhan

Identifiers

NCT: NCT07667829 · 2024ZD0526703

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗