153 Participants Needed

Norepinephrine vs Vasopressin for Heart Surgery Patients

RJ
Overseen ByRoberta Johnson
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: The Cleveland Clinic
Must be taking: Vasopressors
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MG

Mariya Geube, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: use of vasopressinActive Control1 Intervention
Group II: use of norepinephrineActive Control1 Intervention

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

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Approved in United States as Levophed for:
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Approved in Canada as Norepinephrine Bitartrate for:
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Approved in European Union as Noradrenaline for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+
Unbiased ResultsWe believe in providing patients with all the options.
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