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

NCT04501861 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20-301
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• 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

  during 20 minute period after chest closure

Secondary Outcomes (1)

• RV Free Wall Strain

  during 20 minutes period after chest closure

Study Arms (2)

use of vasopressin

ACTIVE COMPARATOR

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

Drug: Norepinephrine

use of norepinephrine

ACTIVE COMPARATOR

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

Drug: Vasopressin

Interventions

Vasopressin DRUG

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

use of norepinephrine

Norepinephrine DRUG

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

use of vasopressin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Vasopressins; Norepinephrine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Mariya Geube
• Organization: Cleveland Clinic Foundation

Geubem@ccf.org

216-444-2779

Study Officials

• Mariya Geube, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cluster crossover study

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: November 5, 2020
• Primary Completion: August 22, 2023
• Study Completion: December 31, 2024
• Last Updated: March 24, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-03

Locations

US (1)