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

NCT05492968 | Unknown Phase 4 DMC

• 1 other identifier: RACE_01
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Norepinephrine; Epinephrine; Phenylephrine; Major abdominal surgery; Intraoperative Cardiac Output; Intraoperative Hemodynamic; Intraoperative Perfusion

Outcome Measures

Primary Outcomes (1)

• Intraoperative cardiac output

  Time weighted average of intraoperative cardiac output

  Intraoperative

Secondary Outcomes (2)

• Secondary Outcome 1: Intraoperative brain regional oxygen saturation

  Intraoperative

• Secondary Outcome 2: Intraoperative tissue regional oxygen saturation

  Intraoperative

Other Outcomes (9)

• Tertiary Outcome 1: NT-proBNP

  Within the first three postoperative days

• Tertiary Outcome 2: Troponin T

  Within the first three postoperative days

• Tertiary Outcome 3: Copeptin

  Within the first three postoperative days

Study Arms (3)

Epinephrine Group

EXPERIMENTAL

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.

Drug: Epinephrin

Norepinephrine Group

ACTIVE COMPARATOR

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.

Drug: Norepinephrine

Phenylephrine Group

ACTIVE COMPARATOR

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.

Drug: Phenylephrine

Interventions

Epinephrin DRUG

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.

Epinephrine Group

Norepinephrine DRUG

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.

Norepinephrine Group

Phenylephrine DRUG

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.

Phenylephrine Group

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical University of Graz: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low; Cardiac Output, High

Interventions

Epinephrine; Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Christian Reiterer, MD

CONTACT

0043 1 40400; christian.reiterer@meduniwien.ac.at

Alexander Taschner, MD

CONTACT

004340400; alexander.taschner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 9, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 31, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)