The effect of epinephrine, norepinephrine and phenylephrine on intraoperative hemodynamic performance – a prospective double-blinded randomized clinical trial

Phase 4

Not yet recruiting

• Conditions: Patients undergoing open major abdominal surgery

• Registration Number: 2024-517373-25-00
• Lead Sponsor: Medical University Of Vienna

Brief Summary

Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 225

Inclusion Criteria

≥ 45 years old

Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least 2 hours

ASA physical status ≥ 2

At least one of the following risk factors (a-j): a. Age ≥ 75 years b. History of peripheral arterial disease c. History of coronary artery disease d. History of stroke or transient ischemic attack e. History of chronic kidney disease f. Diabetes requiring medical treatment g. Current smoking or history of 15 pack-years h. History of heart failure i. Preoperative high-sensitivity Troponin T ≥ 14ng.L-1 j. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.		Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1: Brain regional oxygen saturation (brSO2) – TWA of intraoperative brSO2 values between the groups		Secondary outcome 1: Brain regional oxygen saturation (brSO2) – TWA of intraoperative brSO2 values between the groups
Secondary outcome 2: Tissue regional oxygen saturation (trSO2) – TWA of intraoperative trSO2 values between the groups		Secondary outcome 2: Tissue regional oxygen saturation (trSO2) – TWA of intraoperative trSO2 values between the groups

Trial Locations

Locations (1)

Medical University Of Vienna; 🇦🇹 Vienna, Austria

Medical University Of Vienna

🇦🇹Vienna, Austria

Christian Reiterer

Site contact

+4314040020760

christian.reiterer@meduniwien.ac.at