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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 22, 2023

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.

Interventions

• Drug: Norepinephrine
  • Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients
• Drug: Vasopressin
  • Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients

Arms, Groups and Cohorts

• Active Comparator: The use of vasopressin compared with norepinephrine
  • The investigator 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.
• Active Comparator: The use of norepinephrine compared with vasopressin
  • The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.

Clinical Trial Outcome Measures

Primary Measures

• mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively.
  • Time Frame: during surgery
  • Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • The Cleveland Clinic
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Mariya Geube, MD, Principal Investigator, The Cleveland Clinic