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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212874
First Posted: October 1, 2010
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
Results First Submitted: April 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 35   35   70 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      23  65.7%      19  54.3%      42  60.0% 
>=65 years      12  34.3%      16  45.7%      28  40.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.4  (11.6)   61.6  (13.2)   61.5  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  28.6%      10  28.6%      20  28.6% 
Male      25  71.4%      25  71.4%      50  71.4% 
Region of Enrollment 
[Units: Participants]
     
United States   35   35   70 
Body mass index kg/m^2 
[Units: Kg/m^2]
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: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours ]

2.  Secondary:   Title: Systolic Hypertension   [ Time Frame: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours ]


  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
First Submitted: September 23, 2010
First Posted: October 1, 2010
Results First Submitted: April 5, 2016
Results First Posted: August 17, 2016
Last Update Posted: November 30, 2017