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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04501861

Collaborator

(none)

150

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Drug: Norepinephrine Drug: Vasopressin	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 5, 2020

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Feb 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Vasopressin Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
Active Comparator: The use of norepinephrine compared with vasopressin The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.	Drug: Norepinephrine Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients

Arm

Intervention/Treatment

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.

Drug: Vasopressin

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

Active Comparator: The use of norepinephrine compared with vasopressin

The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.

Drug: Norepinephrine

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

Outcome Measures

Primary Outcome Measures

mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Mariya Geube, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT04501861

Other Study ID Numbers:

20-301

First Posted:

Aug 6, 2020

Last Update Posted:

Oct 13, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021