Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
This study is currently recruiting participants.
Verified January 2013 by Loma Linda University
Sponsor:
Loma Linda University
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01212874
First received: September 23, 2010
Last updated: January 8, 2013
Last verified: January 2013
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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:
- 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 extent of diastolic hypotension below the clinical target range (measured as area under the curve below the lower diastolic pressure expressed in mmHg*min/hr
Secondary Outcome Measures:
- Title: Systolic or diastolic hypertension; systolic hypotension [ Time Frame: Duration: during infusion of study drug ] [ Designated as safety issue: No ]drug dose; time to BP control; infusion duration; need to stop study drug; tachycardia; postbypass HR; pacemaker placement; drug infusion to support separation from bypass; time to extubation; ICU and hospital length of stay; new atrial fibrillation or organ dysfunction
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Nitroglycerin |
Drug: esmolol
esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
|
| Active Comparator: Esmolol |
Drug: nitroglycerin
nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| 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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212874
Contacts
| Contact: Richard L Applegate, MD | 909-558-8493 | rapplegate@llu.edu |
| Contact: Patricia Moore, CCRP | 909-558-8493 | pamoore@llu.edu |
Locations
| United States, California | |
| Loma Linda University | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Richard L Applegate II, MD 909-558-4475 rapplegate@llu.edu | |
| Contact: Patricia Moore, CCRP 909-558-8493 pamoore@llu.edu | |
| Principal Investigator: Richard L Applegate II, MD | |
Sponsors and Collaborators
Loma Linda University
Investigators
| Principal Investigator: | Richard L Applegate II, MD | Loma Linda University |
More Information
No publications provided
| 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 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Nitroglycerin Esmolol Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions 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 May 16, 2013