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Trial record 20 of 1241 for:    adenosine

Dexmedetomidine and Adenosine: Therapeutic Use for SVT

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.
 
ClinicalTrials.gov Identifier: NCT01495481
Recruitment Status : Completed
First Posted : December 20, 2011
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Gaurav Arora, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 15, 2011
First Posted Date  ICMJE December 20, 2011
Results First Submitted Date  ICMJE February 18, 2016
Results First Posted Date  ICMJE March 28, 2017
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Termination of SVT [ Time Frame: Within 3 minutes ]
Number of participants with SVT Termination within 3 minutes of medication administration
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
Termination of SVT [ Time Frame: Within 3 minutes ]
SVT Termination within 3 minutes of dexmedetomidine administration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT [ Time Frame: 1 minute ]
    Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination
  • Number of Participants With Tachyarrhythmias After Medication Administration [ Time Frame: 10 minutes ]
    Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration
  • Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration [ Time Frame: 10 minutes ]
    Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • Incidence and duration of sinus pause or asystole after termination of SVT [ Time Frame: 1 minute ]
    Evaluation of the incidence and duration of asystole, after dexmedetomidine vs. adenosine induced SVT termination
  • Incidence of Tachyarrhythmias [ Time Frame: 10 minutes ]
    Incidence of Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) arrhythmias after dexmedetomidine vs. adenosine administration
  • Hypotension and hypertension [ Time Frame: 10 minutes ]
    Blood pressure changes after dexmedetomidine vs. adenosine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine and Adenosine: Therapeutic Use for SVT
Official Title  ICMJE Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia
Brief Summary The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).
Detailed Description In 2006 the investigator found that dexmedetomidine, an alpha-2 adrenergic agonist with primarily sedative properties, possesses additional anti-arrhythmic properties. So far the investigator has found that dexmedetomidine has the ability to prevent or terminate arrhythmias like atrial ectopic tachycardia (85% success) and junctional ectopic tachycardia (75% success). The most dramatic effect however was observed in the acute termination of reentrant SVT with a success rate of > 96%. More importantly we found that dexmedetomidine terminates SVT without causing any sinus pause or asystole (frequently seen with adenosine) and thus avoiding the feeling of "impending doom". In this study adenosine is being compared head to head with dexmedetomidine in a cross over study, for both safety and efficacy when given for the termination of SVT in the electrophysiology (EP) lab. Additional EP parameters will be measured to elucidate the exact site of dexmedetomidine's mechanism of action.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Supraventricular Tachycardia
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Dexmedetomidine 2 mcg/kg, Intravenous push
    Other Name: Precedex
  • Drug: Adenosine
    Stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Study Arms  ICMJE Experimental: Adenosine and Dexmedetomidine
Patients will receive adenosine and then dexmedetomidine for the termination of SVT
Interventions:
  • Drug: Dexmedetomidine
  • Drug: Adenosine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2011)
30
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients between the age of 5 - 30 years old, who are scheduled for cardiac electrophysiology study for evaluation of reentrant SVT

Exclusion Criteria:

  • Severe Heart Failure
  • Presence of of any other antiarrhythmic medication within 24 hours of enrollment
  • Third degree heart block
  • Sick Sinus Syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01495481
Other Study ID Numbers  ICMJE PRO11070129
PRE-11-010 ( Other Grant/Funding Number: Hospira, Inc )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gaurav Arora, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gaurav Arora, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP