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

Phase 3

Completed

• Conditions: Cardiac Disease
• Interventions: Drug: Norepinephrine; Drug: Vasopressin

• Registration Number: NCT04501861
• Lead Sponsor: The Cleveland Clinic

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.

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 Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Study Start: 2020-11-05
• Primary Completion: 2023-08-22
• Results First Submitted: 2024-10-08
• Study Completion: 2024-12-31
• Results First Submitted QC: 2025-01-03
• Results First Posted: 2025-01-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
use of vasopressin	Norepinephrine	Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
use of norepinephrine	Vasopressin	Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients

Primary Outcome Measures

Name	Time	Method
mPAP-to-MAP Ratio	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

Secondary Outcome Measures

Name	Time	Method
RV Free Wall Strain	during 20 minutes period after chest closure	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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States