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This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitroglycerin | Active Comparator | nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass |
|
| Esmolol | Active Comparator | esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitroglycerin | Drug | nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour | Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass | Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Title: Systolic Hypertension | Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass | Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Applegate II, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esmolol | esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension. |
| FG001 | Nitroglycerin | nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitroglycerin | nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour | Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass | Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis. | Posted | Median | 95% Confidence Interval | mmHg*min/prebypass hour | Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esmolol | esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension. |
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Only 25 of 70 patients received the assigned intervention. Individualized BP ranges based on day of surgery measurement likely decreased treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Moore | Loma Linda University Anesthesiology | 1-909-558-4475 | pamoore@llu.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| C036604 | esmolol |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| esmolol | Drug | esmolol will be administered by infusion following a step up / step down protocol to control hypertension. |
|
| Esmolol |
esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body mass index kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery. |
|
|
|
| Secondary | Title: Systolic Hypertension | Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass | Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis. | Posted | Median | 95% Confidence Interval | mmHg*min / prebypass hour | Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours |
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|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Nitroglycerin | nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery. | 0 | 35 | 0 | 35 |
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