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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: Drug: Norepinephrine; Drug: Vasopressin

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: use of vasopressin; Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients	Drug: Norepinephrine; 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
Active Comparator: use of norepinephrine; Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients	Drug: Vasopressin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during 20 minutes period after chest closure

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Mariya Geube, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): August 22, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Hemostatics; Coagulants; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Natriuretic Agents; Sympathomimetics; Vasoconstrictor Agents; Antidiuretic Agents; Norepinephrine; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: 20-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No