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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: nitroglycerin; Drug: esmolol

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Richard L Applegate II, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: September 30, 2010
• First Posted (ESTIMATE): October 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Adrenergic beta-1 Receptor Antagonists; Nitroglycerin; Esmolol
• Other Study ID Numbers: 5100218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO