Vasopressor Agents in Pulmonary Hypertension Crisis

June 21, 2026 updated by: Qing Gu, China National Center for Cardiovascular Diseases

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 10037
        • Chinese Academy of Medical Sciences, Fuwai Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangdong Provincial People's Hospital
        • Contact:
    • Wuhan
      • Wuhan, Wuhan, China, 430072
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Gangcheng Zhang
          • Phone Number: +86 027-68756878
          • Email: zgcsir@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Norepinephrine group
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: 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.
Experimental: Dopamine group
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: 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
Experimental: Epinephrine group
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality within 28 days
Time Frame: 28 days after enrolment
28 days after enrolment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Haemodynamic parameters
Time Frame: Haemodynamic parameters at H0, H6, H24, H48 and H72
Haemodynamic parameters at H0, H6, H24, H48 and H72
Severe arrhythmia (ventricular tachycardia, ventricular fibrillation)
Time Frame: Time of onset of severe arrhythmia
Time of onset of severe arrhythmia
Adverse effects of vasopressors
Time Frame: Time at which adverse effects occur
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)
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
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024ZD0526703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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