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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01212874
First received: September 23, 2010
Last updated: July 6, 2016
Last verified: July 2016
Results First Received: April 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: nitroglycerin
Drug: esmolol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Esmolol esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
Nitroglycerin nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.

Participant Flow:   Overall Study
    Esmolol     Nitroglycerin  
STARTED     35     35  
Received Allocated Intervention     13     12  
COMPLETED     13     12  
NOT COMPLETED     22     23  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nitroglycerin

nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass

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

Esmolol

esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass

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

Total Total of all reporting groups

Baseline Measures
    Nitroglycerin     Esmolol     Total  
Number of Participants  
[units: participants]
  35     35     70  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     19     42  
>=65 years     12     16     28  
Age  
[units: years]
Mean (Standard Deviation)
  61.4  (11.6)     61.6  (13.2)     61.5  (12.4)  
Gender  
[units: participants]
     
Female     10     10     20  
Male     25     25     50  
Region of Enrollment  
[units: participants]
     
United States     35     35     70  
Body mass index kg/m^2  
[units: kg/m2]
Mean (Standard Deviation)
  29.8  (5.6)     29.5  (7.7)     29.6  (6.7)  



  Outcome Measures
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1.  Primary:   Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour   [ Time Frame: Participation could last up to 2 weeks, representing the day of surgery until discharge from the hospital. ]

2.  Secondary:   Title: Systolic Hypertension   [ Time Frame: Duration: during infusion of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only 25 of 70 patients received the assigned intervention. Individualized BP ranges based on day of surgery measurement likely decreased treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Patricia Moore
Organization: Loma Linda University Anesthesiology
phone: 1-909-558-4475
e-mail: pamoore@llu.edu



Responsible Party: Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier: NCT01212874     History of Changes
Other Study ID Numbers: 5100218
Study First Received: September 23, 2010
Results First Received: April 5, 2016
Last Updated: July 6, 2016
Health Authority: United States: Institutional Review Board