Cardiac DiseasePhase 3NCT04501861

Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:

A Phase 3 study testing Vasopressin and Norepinephrine in people with Cardiac Disease, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline, and RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Cardiac Disease
What is being tested?: Vasopressin and Norepinephrine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2020to 31 Dec 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults> 18 years of age
Elective cardiac surgery with the use of CPB
Patients with pulmonary artery catheter insertion
Systemic hypotension (MAP < 70 mmHg) requiring continuous infusion of vasopressor

Who cannot join

Transplant surgery
Ventricular assist device implantation other than intra-aortic balloon counter-pulsation
Pulmonary endarterectomy
Thoracoabdominal aneurysm repair
Inhalational pulmonary vasodilators (e.g. Epoprostenol) administration before insertion of pulmonary artery catheter
Vasopressin is started as the first choice of pressor per clinical staff discretion

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: a Comparative-effectiveness Quality Project

Read the detailed description

The specific aims of our study are to compare 1) the relative increase in the mPAP with the same unit increase in MAP adjusted for baseline and 2) RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery. We hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support. Second, we will test the hypothesis that vasopressin is associated with improved right ventricular global longitudinal strain compared to norepinephrine in patients requiring vasopressor support during cardiac surgery.

Conditions: Cardiac Disease
Being tested: Vasopressin, Norepinephrine
Medical subject headings: Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VasopressinDrug
Vasopressin (20 IU/100 ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps
NorepinephrineDrug
Norepinephrine (4 mg/250ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps

Study groups in NCT04501861
Study group	Role	What they receive
use of vasopressin	Active comparator	Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients Receives: Drug: Norepinephrine
use of norepinephrine	Active comparator	Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients Receives: Drug: Vasopressin

What is being measured

The primary outcome is the main question the study is designed to answer.

mPAP-to-MAP Ratio
The intraoperative mean pulmonary artery pressure(mPAP) adjusted for systemic mean arterial pressure(MAP), using a time-weighted average mPAP-to-MAP ratio measured during 20 minute period after chest closure
Measured: during 20 minute period after chest closure

Secondary outcomes (1)

RV Free Wall Strain
Right Ventricular Free Wall Longitudinal Strain (RV FWLS) is a measure of the deformation (strain) of the right ventricle's free wall (the part not attached to the septum) during contraction. It quantifies how much the myocardium in the free wall of the right ventricle shortens along its longitudinal axis (base to apex) during systole (contraction). It is expressed as a negative percentage (%), where more negative values indicate better contractility (e.g., -20% is better than -10%). In this study, it was measured by transesophageal echocardiography in the 2D mid-esophageal four-chamber view during a steady state period after chest closure
Measured: during 20 minutes period after chest closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202031 Dec 2024

First posted6 Aug 2020
Study start5 Nov 2020
Primary completion22 Aug 2023
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized cluster crossover study
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04501861
Sponsor's protocol ID: 20-301
Status last verified: Oct 2026
First submitted: 3 Aug 2020
Last updated: 27 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: a Comparative-effectiveness Quality Project
ClinicalTrials.gov ID: NCT04501861
Acronym / sponsor ID: 20-301
Conditions: Cardiac Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 5 Nov 2020 (actual)
Primary completion: 22 Aug 2023 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 6 Aug 2020 (actual)
Results: Posted 9 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Randomized cluster crossover study

Arm	Type	Receives
use of vasopressin	Active comparator	Drug: NorepinephrineHemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
use of norepinephrine	Active comparator	Drug: VasopressinHemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults> 18 years of age
Elective cardiac surgery with the use of CPB
Patients with pulmonary artery catheter insertion
Systemic hypotension (MAP < 70 mmHg) requiring continuous infusion of vasopressor

Key exclusion criteria (6 listed)

Transplant surgery
Ventricular assist device implantation other than intra-aortic balloon counter-pulsation
Pulmonary endarterectomy
Thoracoabdominal aneurysm repair
Inhalational pulmonary vasodilators (e.g. Epoprostenol) administration before insertion of pulmonary artery catheter

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VasopressinVasopressin (20 IU/100 ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps	Drug	use of norepinephrine
NorepinephrineNorepinephrine (4 mg/250ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps	Drug	use of vasopressin

Primary outcome

mPAP-to-MAP Ratio
Time frame: during 20 minute period after chest closure
The intraoperative mean pulmonary artery pressure(mPAP) adjusted for systemic mean arterial pressure(MAP), using a time-weighted average mPAP-to-MAP ratio measured during 20 minute period after chest closure

1 secondary outcome

RV Free Wall Strain
Time frame: during 20 minutes period after chest closure

Results and safety

Results posted to the registry on 9 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Use of Vasopressin	70	0
The Use of Norepinephrine	83	0

Primary outcome: mPAP-to-MAP Ratio

Time frame: during 20 minute period after chest closure. Mean (Standard Deviation). Unit: ratio of mPAP-to-MAP

Measure	The Use of Vasopressin n = 70	The Use of Norepinephrine n = 83
mPAP-to-MAP ratio	0.394 (0.086)	0.385 (0.094)
mPAP-to-MAP ratio with preop pulmonary hypertension	0.42 (0.082)	0.40 (0.093)
mPAP-to-MAP ratio without preop pulmonary hypertension	0.37 (0.084)	0.36 (0.092)

The Use of Vasopressin vs The Use of Norepinephrine: Mean Difference (Final Values): 0.01 (95% CI -0.043 to 0.022), p = 0.53, Mixed Models Analysis
The Use of Vasopressin vs The Use of Norepinephrine: Mean Difference (Final Values): -0.022 (95% CI -0.061 to 0.016), p = 0.26, Mixed Models Analysis
The Use of Vasopressin vs The Use of Norepinephrine: Mean Difference (Final Values): -0.0035 (95% CI -0.05 to 0.043), p = 0.88, Mixed Models Analysis

Population analysed: Not all the patients in the 2 groups with preoperative pulmonary arterial hypertension, we only included the eligible patients.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were not monitored/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Use of Vasopressin	0 of 0	0 of 0	0
The Use of Norepinephrine	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Our study protocol excluded patients at particularly high risk for acute right ventricular failure. Thus, our conclusions should not be extrapolated to such vulnerable populations. Our analysis was not adequately powered to evaluate mortality and other major clinical outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mariya Geube, MD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vasopressin and Norepinephrine in people with Cardiac Disease, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mPAP-to-MAP Ratio (time frame: during 20 minute period after chest closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.