Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass(CPB) in Cardiac Surgery: a Randomized, Controlled Trial|
- Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass in cardiac surgery: a randomized, clinical trial [ Time Frame: Participation could last up to 2 weeks, representing the day of surgery until discharge from the hospital. ] [ Designated as safety issue: No ]The extent of diastolic hypotension below the clinical target range (measured as area under the curve below the lower diastolic pressure expressed in mmHg*min/hr
- Title: Systolic or diastolic hypertension; systolic hypotension [ Time Frame: Duration: during infusion of study drug ] [ Designated as safety issue: No ]drug dose; time to BP control; infusion duration; need to stop study drug; tachycardia; postbypass HR; pacemaker placement; drug infusion to support separation from bypass; time to extubation; ICU and hospital length of stay; new atrial fibrillation or organ dysfunction
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Nitroglycerin||
esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
|Active Comparator: Esmolol||
nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212874
|United States, California|
|Loma Linda University|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Richard L Applegate II, MD||Loma Linda University|