N/A
N=70
Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01212874 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour — 97.9; 45.6 mmHg*min/prebypass hour — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nitroglycerin (Drug); esmolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour |
97.9; 45.6 | 0.21 |
| SECONDARY Title: Systolic Hypertension |
48.6; 145.8 | 0.04 sig |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01212874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.