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The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance (RACE)

Primary Purpose

Cardiac Output, Low, Cardiac Output, High, Perfusion; Complications

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Epinephrin
Norepinephrine
Phenylephrine
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Output, Low focused on measuring Norepinephrine, Epinephrine, Phenylephrine, Major abdominal surgery, Intraoperative Cardiac Output, Intraoperative Hemodynamic, Intraoperative Perfusion

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 45 years old
  • Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least two hours
  • ASA physical status ≥ 2
  • At least one of the following risk factors:

    1. Age ≥75years
    2. History of peripheral arterial disease
    3. History of coronary artery disease
    4. History of stroke or transient ischemic attack/Stroke
    5. History of chronic kidney disease
    6. Diabetes requiring medical treatment
    7. Current smoking or history of 15 pack-years
    8. History of heart failure
    9. Preoperative high-sensitivity Troponin T ≥14ng.L-1
    10. Preoperative NT-proBNP ≥200 pg.mL-1

Exclusion Criteria:

  1. Scheduled for pheochromocytoma surgery
  2. Scheduled for liver and kidney transplantation
  3. Requiring preoperative intravenous vasopressor medications
  4. Contraindications to epinephrine, norepinephrine or phenylephrine per clinical judgement
  5. Permanent atrial fibrillation
  6. Preoperative heart rate >110 bpm

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Epinephrine Group

Norepinephrine Group

Phenylephrine Group

Arm Description

Patients in the epinephrine group will receive a continuous infusion containing epinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.

Patients in the norepinephrine group will receive a continuous infusion containing norepinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.

Patients in the phenylephrine group will receive a continuous infusion containing phenylephrine with a concentration of 0.2mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.

Outcomes

Primary Outcome Measures

Intraoperative cardiac output
Time weighted average of intraoperative cardiac output

Secondary Outcome Measures

Secondary Outcome 1: Intraoperative brain regional oxygen saturation
Time weighted average of intraoperative brain regional oxygen saturation
Secondary Outcome 2: Intraoperative tissue regional oxygen saturation
Time weighted average of intraoperative tissue regional oxygen saturation

Full Information

First Posted
July 28, 2022
Last Updated
October 17, 2022
Sponsor
Medical University of Vienna
Collaborators
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05492968
Brief Title
The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance
Acronym
RACE
Official Title
The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance - a Prospective Double-blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of catecholamines for blood pressure and hemodynamic management is essential during undergoing surgery. The type of the catecholamine with the most clinical meaningful effect is still unknown. Therefore, the investigators evaluate the effect of intraoperative continuous infusion of epinephrine, norepinephrine and phenylephrine on intraoperative cardiac output. The investigators further evaluate the effect of epinephrine, norepinephrine and phenylephrine on regional brain and regional tissue oxygenation during surgery.
Detailed Description
Background: The use of catecholamines for blood pressure and hemodynamic management is essential during undergoing surgery. The type of the catecholamine with the most clinical meaningful effect is still unknown. Therefore, the investigators evaluate the effect of intraoperative continuous infusion of epinephrine, norepinephrine and phenylephrine on intraoperative cardiac output. The investigators further evaluate the effect of epinephrine, norepinephrine and phenylephrine on regional brain and regional tissue oxygenation during surgery. Methods: The study will include 225 patients ≥ 45 years of age undergoing moderate- to high-risk major open abdominal surgery lasting at least two hours in this prospective double-blinded randomized clinical trial. Patients will be randomly assigned to receive a continuous infusion of epinephrine, norepinephrine or phenylephrine for intraoperative blood pressure management. The primary outcome will be time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine or phenylephrine. The secondary outcomes will be time weighted average of intraoperative brain regional oxygen saturation (brSO2) and tissue regional oxygen saturation (trSO2) between the groups. Statistics: For the primary outcome, TWA of intraoperative cardiac output between the groups will be analyzed using an ANOVA. The primary outcome, TWA of intraoperative brSO2 and TWA of intraoperative trSO2 will be analysed using an ANOVA. Level of originality: Data regarding the hemodynamic effects of commonly used intraoperative vasopressors on cardiac output are limited. In detail, effects of different types of catecholamines on hemodynamic parameters and subsequently tissue perfusion in the operative setting are lacking. This study will give further information of the different hemodynamic effects of the most used clinical used catecholamines which are used for intraoperative blood pressure management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low, Cardiac Output, High, Perfusion; Complications
Keywords
Norepinephrine, Epinephrine, Phenylephrine, Major abdominal surgery, Intraoperative Cardiac Output, Intraoperative Hemodynamic, Intraoperative Perfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epinephrine Group
Arm Type
Experimental
Arm Description
Patients in the epinephrine group will receive a continuous infusion containing epinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.
Arm Title
Norepinephrine Group
Arm Type
Active Comparator
Arm Description
Patients in the norepinephrine group will receive a continuous infusion containing norepinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.
Arm Title
Phenylephrine Group
Arm Type
Active Comparator
Arm Description
Patients in the phenylephrine group will receive a continuous infusion containing phenylephrine with a concentration of 0.2mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.
Intervention Type
Drug
Intervention Name(s)
Epinephrin
Intervention Description
Patients in the epinephrine group will receive a continuous infusion containing epinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Patients in the norepinephrine group will receive a continuous infusion containing norepinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
Patients in the phenylephrine group will receive a continuous infusion containing phenylephrine with a concentration of 0.2mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.
Primary Outcome Measure Information:
Title
Intraoperative cardiac output
Description
Time weighted average of intraoperative cardiac output
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Secondary Outcome 1: Intraoperative brain regional oxygen saturation
Description
Time weighted average of intraoperative brain regional oxygen saturation
Time Frame
Intraoperative
Title
Secondary Outcome 2: Intraoperative tissue regional oxygen saturation
Description
Time weighted average of intraoperative tissue regional oxygen saturation
Time Frame
Intraoperative
Other Pre-specified Outcome Measures:
Title
Tertiary Outcome 1: NT-proBNP
Description
Maximum concentration of NT-proBNP in the first three postoperative days
Time Frame
Within the first three postoperative days
Title
Tertiary Outcome 2: Troponin T
Description
Maximum concentration of Troponin T in the first three postoperative days
Time Frame
Within the first three postoperative days
Title
Tertiary Outcome 3: Copeptin
Description
Maximum concentration of Copeptin in the first three postoperative days
Time Frame
Within the first three postoperative days
Title
Exploratory Outcome 1:
Description
Incidence of MINS
Time Frame
Within the first three postoperative days
Title
Exploratory Outcome 2:
Description
Incidence of atrial fibrillation
Time Frame
Through study completion, on average 7 days
Title
Exploratory Outcome 3:
Description
Incidence of acute kidney injury
Time Frame
During hospitalization, on average 7 days
Title
Exploratory Outcome 4:
Description
Incidence of myocardial infarction
Time Frame
During hospitalization, on average 7 days
Title
Exploratory Outcome 5:
Description
Incidence of stroke
Time Frame
During hospitalization, on average 7 days
Title
Exploratory Outcome 6:
Description
Incidence of wound related complications
Time Frame
During hospitalization, on average 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 45 years old Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least two hours ASA physical status ≥ 2 At least one of the following risk factors: Age ≥75years History of peripheral arterial disease History of coronary artery disease History of stroke or transient ischemic attack/Stroke History of chronic kidney disease Diabetes requiring medical treatment Current smoking or history of 15 pack-years History of heart failure Preoperative high-sensitivity Troponin T ≥14ng.L-1 Preoperative NT-proBNP ≥200 pg.mL-1 Exclusion Criteria: Scheduled for pheochromocytoma surgery Scheduled for liver and kidney transplantation Requiring preoperative intravenous vasopressor medications Contraindications to epinephrine, norepinephrine or phenylephrine per clinical judgement Permanent atrial fibrillation Preoperative heart rate >110 bpm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Reiterer, MD
Phone
0043 1 40400
Ext
20760
Email
christian.reiterer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Taschner, MD
Phone
004340400
Ext
20760
Email
alexander.taschner@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Reiterer, MD
Phone
004340400
Ext
20760
Email
christian.reiterer@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance

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