Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
Primary Purpose
Cardiac Disease
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Norepinephrine
Vasopressin
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Disease
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
The use of vasopressin compared with norepinephrine
The use of norepinephrine compared with vasopressin
Arm Description
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.
The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04501861
Brief Title
Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
Official Title
Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: a Comparative-effectiveness Quality Project
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
August 22, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The use of vasopressin compared with norepinephrine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The use of norepinephrine compared with vasopressin
Arm Type
Active Comparator
Arm Description
The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
Primary Outcome Measure Information:
Title
mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively.
Description
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.
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariya Geube, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
We'll reach out to this number within 24 hrs