NCT04501861

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Disease

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2020-11-05
• Primary completion: 2023-08-22
• Completion: 2024-12-31
• First posted: 2020-08-06
• Last updated: 2025-03-24
• Results posted: 2025-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study