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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Cardiac Disease

Treatments: Drug: Vasopressin; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04501861

20-301

Details and patient eligibility

About

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 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.

Enrollment: 153 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

use of vasopressin

Active Comparator group

Description:

Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients

Treatment:

Drug: Norepinephrine

use of norepinephrine

Active Comparator group

Description:

Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients

Treatment:

Drug: Vasopressin