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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
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
August 3, 2020
Last Updated
August 22, 2023
Sponsor
The Cleveland Clinic
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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:

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