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

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04501861
• Other study ID #: 20-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 5, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively.	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.	during surgery