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The effect of catecholamines on intraoperative hemodynamics

Phase 1
Conditions
Patients > 45 years of age at-risk for cardiovascular complications undergoing moderate- to high-risk major open abdominal surgery.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2022-001023-32-AT
Lead Sponsor
Medical University of Vienna
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
225
Inclusion Criteria

1. = 45 years old
2. Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least two hours
3. ASA physical status = 2
4. At least one of the following risk factors:
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 ng.L-1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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