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
  Purpose
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).

Condition Intervention
Hypertension
Drug: nitroglycerin
Drug: esmolol

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 70
Study Start Date: December 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nitroglycerin
nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass
Drug: nitroglycerin
nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
Active Comparator: Esmolol
esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass
Drug: esmolol
esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212874

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Richard L Applegate II, MD Loma Linda University
  More Information

Responsible Party: Richard Applegate, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01212874     History of Changes
Other Study ID Numbers: 5100218 
Study First Received: September 23, 2010
Results First Received: April 5, 2016
Last Updated: July 6, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Nitroglycerin
Esmolol
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016