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

NCT01212874 | Completed Results DMC

• 1 other identifier: 5100218
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Title: Systolic Hypertension

  Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours

Study Arms (2)

Nitroglycerin

ACTIVE COMPARATOR

nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass

Drug: nitroglycerin

Esmolol

ACTIVE COMPARATOR

esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass

Drug: esmolol

Interventions

nitroglycerin DRUG

nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.

Nitroglycerin

esmolol DRUG

esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

Esmolol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• severe LV (left ventricle)dysfunction (EF \< 35%).
• emergency procedures.
• procedures with combined carotid artery surgery.
• patients at high risk for stroke.
• hemodynamically significant dysrhythmias.
• pre-existing atrial fibrillation or high degree AV (atrioventricular block).
• pacemaker dependency.
• known sensitivity to beta blockers.
• patient refusal.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nitroglycerin; esmolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Limitations and Caveats

Only 25 of 70 patients received the assigned intervention. Individualized BP ranges based on day of surgery measurement likely decreased treatment.

Results Point of Contact

• Title: Patricia Moore
• Organization: Loma Linda University Anesthesiology

pamoore@llu.edu

1-909-558-4475

Study Officials

• Richard L Applegate II, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: October 1, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 1, 2019
• Results First Posted: August 17, 2016

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)