Health TrialsbyHealthPanel

Vasopressor Agents in Pulmonary Hypertension Crisis

ConditionsPulmonary Arterial Hypertension (PAH)Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Hypertension, Pulmonary
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Norepinephrine groupExperimental treatment 1 intervention
Group B: Dopamine groupExperimental treatment 1 intervention
Group C: Epinephrine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality within 28 days

Time frame
28 days after enrolment

Secondary outcomes

1

Haemodynamic parameters

Time frame
Haemodynamic parameters at H0, H6, H24, H48 and H72
2

Severe arrhythmia (ventricular tachycardia, ventricular fibrillation)

Time frame
Time of onset of severe arrhythmia
3

Adverse effects of vasopressors

Time frame
Time at which adverse effects occur
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: