Patients > 45 years of age at-risk for cardiovascular complications undergoing moderate- to high-risk major open abdominal surgery.
Conditions
Interventions
Trade Name: Suprarenin
Product Name: Suprarenin
Product Code: Epinephrine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: EPINEPHRINE HYDROCHLORIDE
CAS Number: 55-31-2
Current Sponsor
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our primary aim is to evaluate the effect of intraoperative blood pressure therapy with a continuous infusion of epinephrine, norepinephrine, or phenylephrine on TWA of cardiac output in patients at-risk for cardiovascular complications undergoing moderate- to high-risk major open abdominal surgery.;Secondary Objective: Secondary aim 1: Brain regional oxygen saturation (brSO2) Our secondary aim will be to evaluate the effect of epinephrine, norepinephrine and phenylephrine on the TWA of intraoperative brSO2 values. Secondary aim 2: Tissue regional oxygen saturation (trSO2) Our secondary aim will be to evaluate the effect of epinephrine, norepinephrine and phenylephrine on the TWA of intraoperative trSO2 values. Tertiary aims: Cardiac biomarkers Our tertiary outcome will be postoperative maximum concentrations of NT-proBNP, Troponin T and Copeptin between the study groups assessed within the first three postoperative days.;Primary end point(s): Our primary outcome will be intraoperative time-weighted average (TWA) of cardiac index in patients receiving a continuous infusion of epinephrine, norepinephrine or phenylephrine throughout surgery.;Timepoint(s) of evaluation of this end point: Throughout surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcome 1: Brain regional oxygen saturation (brSO2) Our secondary outcome will be TWA of intraoperative brSO2 values assessed via near-infrared spectroscopy. Secondary Outcome 2: Tissue regional oxygen saturation (trSO2) Our secondary outcome will be TWA of intraoperative trSO2 values assessed via near-infrared spectroscopy technology. Tertiary Outcomes: Our tertiary outcomes will be maximum NT-proBNP, Troponin T, and Copeptin concentrations measured within the first three postoperative days between the study groups. Maximum concentrations will be defined as the highest value measured within the first three postoperative days. ;Timepoint(s) of evaluation of this end point: Secondary Outcome 1: Throughout surgery. Secondary Outcome 2: Throughout surgery. Tertiary Outcomes: First three postoperative days. | — |
Countries
Austria
Contacts
Public ContactHead Office
Department, General Intensive Care Medicine and Pain Medicine
Outcome results
None listed