Cardiac Output, Low, Cardiac Output, High, Perfusion; Complications
Conditions
Keywords
Norepinephrine, Epinephrine, Phenylephrine, Major abdominal surgery, Intraoperative Cardiac Output, Intraoperative Hemodynamic, Intraoperative Perfusion
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.
Interventions
DRUGEpinephrin
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.
DRUGNorepinephrine
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.
DRUGPhenylephrine
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.
Sponsors
Medical University of Graz
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative cardiac output | Intraoperative | Time weighted average of intraoperative cardiac output |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome 1: Intraoperative brain regional oxygen saturation | Intraoperative | Time weighted average of intraoperative brain regional oxygen saturation |
| Secondary Outcome 2: Intraoperative tissue regional oxygen saturation | Intraoperative | Time weighted average of intraoperative tissue regional oxygen saturation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcome 1: | Within the first three postoperative days | Incidence of MINS |
| Exploratory Outcome 2: | Through study completion, on average 7 days | Incidence of atrial fibrillation |
| Exploratory Outcome 3: | During hospitalization, on average 7 days | Incidence of acute kidney injury |
| Tertiary Outcome 1: NT-proBNP | Within the first three postoperative days | Maximum concentration of NT-proBNP in the first three postoperative days |
| Exploratory Outcome 5: | During hospitalization, on average 7 days | Incidence of stroke |
| Exploratory Outcome 6: | During hospitalization, on average 7 days | Incidence of wound related complications |
| Exploratory Outcome 4: | During hospitalization, on average 7 days | Incidence of myocardial infarction |
| Tertiary Outcome 2: Troponin T | Within the first three postoperative days | Maximum concentration of Troponin T in the first three postoperative days |
| Tertiary Outcome 3: Copeptin | Within the first three postoperative days | Maximum concentration of Copeptin in the first three postoperative days |
Countries
Austria
Contacts
Primary ContactChristian Reiterer, MD
Backup ContactAlexander Taschner, MD
Outcome results
None listed