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| Name | Class |
|---|---|
| Medical University of Graz | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative cardiac output | Time weighted average of intraoperative cardiac output | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome 1: Intraoperative brain regional oxygen saturation | Time weighted average of intraoperative brain regional oxygen saturation | Intraoperative |
| Secondary Outcome 2: Intraoperative tissue regional oxygen saturation |
| Measure | Description | Time Frame |
|---|---|---|
| Tertiary Outcome 1: NT-proBNP | Maximum concentration of NT-proBNP in the first three postoperative days | Within the first three postoperative days |
| Tertiary Outcome 2: Troponin T | Maximum concentration of Troponin T in the first three postoperative days |
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Reiterer, MD | Contact | 0043 1 40400 | 20760 | christian.reiterer@meduniwien.ac.at |
| Alexander Taschner, MD | Contact | 004340400 | 20760 | alexander.taschner@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D002303 | Cardiac Output, Low |
| D016534 | Cardiac Output, High |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D009638 | Norepinephrine |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| 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. |
|
| 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. |
|
Time weighted average of intraoperative tissue regional oxygen saturation
| Intraoperative |
| Within the first three postoperative days |
| Tertiary Outcome 3: Copeptin | Maximum concentration of Copeptin in the first three postoperative days | Within the first three postoperative days |
| Exploratory Outcome 1: | Incidence of MINS | Within the first three postoperative days |
| Exploratory Outcome 2: | Incidence of atrial fibrillation | Through study completion, on average 7 days |
| Exploratory Outcome 3: | Incidence of acute kidney injury | During hospitalization, on average 7 days |
| Exploratory Outcome 4: | Incidence of myocardial infarction | During hospitalization, on average 7 days |
| Exploratory Outcome 5: | Incidence of stroke | During hospitalization, on average 7 days |
| Exploratory Outcome 6: | Incidence of wound related complications | During hospitalization, on average 7 days |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |