Norepinephrine vs Vasopressin for Heart Surgery Patients

Overseen By Roberta Johnson

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The Cleveland Clinic

Must be taking: Vasopressors

Must not be taking: Inhalational vasodilators

Disqualifiers: Transplant, Ventricular assist, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

153 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mariya Geube, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults over 18 who are having elective heart surgery with a device called CPB and need a pulmonary artery catheter. They must have low blood pressure during surgery needing drugs to raise it. It's not for those getting transplants, certain implants, specific lung surgeries, or using inhaled lung medicines before the study starts.

Inclusion Criteria

I need medication through an IV to maintain my blood pressure.

I am scheduled for heart surgery that will use a heart-lung machine.

I am over 18 years old.

Exclusion Criteria

I am getting a heart pump implant that is not an intra-aortic balloon.

I am scheduled for or have had a surgery to remove blood clots from my lungs.

I am scheduled for surgery to repair an aneurysm in my chest and abdomen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Treatment

Participants receive vasopressor support with either vasopressin or norepinephrine during cardiac surgery

During surgery

1 visit (in-person, during surgery)

Immediate Postoperative Monitoring

Monitoring of mPAP-to-MAP ratio and RV function using transesophageal echocardiography

20 minutes after chest closure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Norepinephrine
• Vasopressin

Trial Overview The study looks at how two drugs, Norepinephrine (NE) and Vasopressin (VP), affect blood pressure in the lungs compared to overall blood pressure during heart surgery. It also checks how these drugs influence right ventricle function when patients need vasopressor support.

Participant Groups

Group I: use of vasopressin Active Control 1 Intervention

Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients

Group II: use of norepinephrine Active Control 1 Intervention

Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients

Norepinephrine is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Levophed for:

• Severe, acute hypotension
• Cardiac arrest

Approved in Canada as Norepinephrine Bitartrate for:

• Severe, acute hypotension
• Cardiac arrest

Approved in European Union as Noradrenaline for:

• Severe, acute hypotension
• Cardiac arrest

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+