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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: esmolol; Drug: nitroglycerin

• Registration Number: NCT01212874
• Lead Sponsor: Loma Linda University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-01
• Study Start: 2010-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2016-04-05
• Results First Submitted QC: 2016-07-06
• Results First Posted: 2016-08-17
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esmolol	esmolol	esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass
Nitroglycerin	nitroglycerin	nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour	Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours	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

Name	Time	Method
Title: Systolic Hypertension	Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours	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

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States