NCT01495481

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

December 15, 2011

Results QC Date

February 18, 2016

Last Update Submit

February 7, 2017

Conditions

Supraventricular Tachycardia

Keywords

Supraventricular TachycardiaSVTReentrant TachycardiaDexmedetomidineAdenosine

Outcome Measures

Primary Outcomes (1)

  • Termination of SVT

    Number of participants with SVT Termination within 3 minutes of medication administration

    Within 3 minutes

Secondary Outcomes (3)

  • Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT

    1 minute

  • Number of Participants With Tachyarrhythmias After Medication Administration

    10 minutes

  • Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration

    10 minutes

Study Arms (1)

Adenosine and Dexmedetomidine

EXPERIMENTAL

Patients will receive adenosine and then dexmedetomidine for the termination of SVT

Drug: DexmedetomidineDrug: Adenosine

Interventions

DexmedetomidineDRUG

Dexmedetomidine 2 mcg/kg, Intravenous push

Also known as: Precedex
Adenosine and Dexmedetomidine
AdenosineDRUG

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

Adenosine and Dexmedetomidine

Eligibility Criteria

Age5 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Severe Heart Failure
  • Presence of of any other antiarrhythmic medication within 24 hours of enrollment
  • Third degree heart block
  • Sick Sinus Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (2)

  • Chrysostomou C, Beerman L, Shiderly D, Berry D, Morell VO, Munoz R. Dexmedetomidine: a novel drug for the treatment of atrial and junctional tachyarrhythmias during the perioperative period for congenital cardiac surgery: a preliminary study. Anesth Analg. 2008 Nov;107(5):1514-22. doi: 10.1213/ane.0b013e318186499c.

    PMID: 18931208BACKGROUND

  • Chrysostomou C, Sanchez-de-Toledo J, Wearden P, Jooste EH, Lichtenstein SE, Callahan PM, Suresh T, O'Malley E, Shiderly D, Haney J, Yoshida M, Orr R, Munoz R, Morell VO. Perioperative use of dexmedetomidine is associated with decreased incidence of ventricular and supraventricular tachyarrhythmias after congenital cardiac operations. Ann Thorac Surg. 2011 Sep;92(3):964-72; discussion 972. doi: 10.1016/j.athoracsur.2011.04.099.

    PMID: 21871284BACKGROUND

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

DexmedetomidineAdenosine

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Dr. Gaurav Arora
Organization
University of Pittsburgh
gaurav.arora@chp.edu
412-692-6054

Study Officials

  • Gaurav Arora, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 20, 2011

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 28, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)