Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01212874
First received: September 23, 2010
Last updated: July 6, 2016
Last verified: July 2016

September 23, 2010
July 6, 2016
December 2010
June 2014   (final data collection date for primary outcome measure)
Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour [ Time Frame: Participation could last up to 2 weeks, representing the day of surgery until discharge from the hospital. ] [ Designated as safety issue: No ]
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
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 number of minutes that blood pressure was below the clinical target range during treatment for high blood pressure.
Complete list of historical versions of study NCT01212874 on ClinicalTrials.gov Archive Site
Title: Systolic Hypertension [ Time Frame: Duration: during infusion of study drug ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
Not Provided
 
Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass(CPB) in Cardiac Surgery: a Randomized, Controlled Trial
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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: nitroglycerin
    nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
  • Drug: esmolol
    esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
  • Active Comparator: Nitroglycerin
    nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass
    Intervention: Drug: nitroglycerin
  • Active Comparator: Esmolol
    esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass
    Intervention: Drug: esmolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients scheduled for cardiac surgery at LLUMC University Hospital will be eligible for participation in this study.

Exclusion Criteria:

  1. severe LV (left ventricle)dysfunction (EF < 35%).
  2. emergency procedures.
  3. procedures with combined carotid artery surgery.
  4. patients at high risk for stroke.
  5. hemodynamically significant dysrhythmias.
  6. pre-existing atrial fibrillation or high degree AV (atrioventricular block).
  7. pacemaker dependency.
  8. known sensitivity to beta blockers.
  9. patient refusal.
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01212874
5100218
Yes
No
Not Provided
Richard Applegate, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Richard L Applegate II, MD Loma Linda University
Loma Linda University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP