Back to resultsA Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT) (AHAvsSIM)
Primary Purpose
Supra-ventricular Tachycardia
Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Adenosine
Sponsored by
About this trial
This is an interventional treatment trial for Supra-ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Svt
- normal blood pressure
- normal mentation
- Give consent
Exclusion Criteria:
- recent coffee
- Allergy to adenosine
- Asthma
- cardiac operations
Sites / Locations
- Steve Biko hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush
Giving adenosine Ising the recommended AHA two syringe method
Outcomes
Primary Outcome Measures
The Number of Patients With First Dose Successful Termination of the Supraventricular Tachycardia to a Sinus Rhythm of Less Than 140 With the AHA Versus a Simplified Method of Adenosine Administration
The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04392362
Brief Title
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)
Acronym
AHAvsSIM
Official Title
A Randomised Controlled Trial of the Standard Versus a Simplified Adenosine Administration Method in the Treatment of Adult Patients With Supra- Ventricular Tachycardia (SVT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
December 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pretoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study to compare non inferiority of giving adenosine with the simplified method vs the AHA method
Detailed Description
tle: A randomised controlled trial of the standard versus a simplified adenosine administration method in the treatment of adult patients with supra- ventricular tachycardia (SVT
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supra-ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomizes Control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Method of giving adenosine at 6mg then 12mg repeated twice to abort svt Intervention is giving the drug in a simplified method mixing it with 20 ml saline as a whole flush
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Giving adenosine Ising the recommended AHA two syringe method
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
A vial of adenosine with 6mg
Primary Outcome Measure Information:
Title
The Number of Patients With First Dose Successful Termination of the Supraventricular Tachycardia to a Sinus Rhythm of Less Than 140 With the AHA Versus a Simplified Method of Adenosine Administration
Description
The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute.
Time Frame
10 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Svt
normal blood pressure
normal mentation
Give consent
Exclusion Criteria:
recent coffee
Allergy to adenosine
Asthma
cardiac operations
Facility Information:
Facility Name
Steve Biko hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20956224
Citation
Neumar RW, Otto CW, Link MS, Kronick SL, Shuster M, Callaway CW, Kudenchuk PJ, Ornato JP, McNally B, Silvers SM, Passman RS, White RD, Hess EP, Tang W, Davis D, Sinz E, Morrison LJ. Part 8: adult advanced cardiovascular life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S729-67. doi: 10.1161/CIRCULATIONAHA.110.970988. Erratum In: Circulation. 2011 Feb 15;123(6):e236. Circulation. 2013 Dec 24;128(25):e480.
Results Reference
background
PubMed Identifier
31665806
Citation
McDowell M, Mokszycki R, Greenberg A, Hormese M, Lomotan N, Lyons N. Single-syringe Administration of Diluted Adenosine. Acad Emerg Med. 2020 Jan;27(1):61-63. doi: 10.1111/acem.13879. Epub 2019 Nov 25. No abstract available.
Results Reference
background
PubMed Identifier
26399663
Citation
Page RL, Joglar JA, Caldwell MA, Calkins H, Conti JB, Deal BJ, Estes NA 3rd, Field ME, Goldberger ZD, Hammill SC, Indik JH, Lindsay BD, Olshansky B, Russo AM, Shen WK, Tracy CM, Al-Khatib SM; Evidence Review Committee Chairdouble dagger. 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2016 Apr 5;133(14):e506-74. doi: 10.1161/CIR.0000000000000311. Epub 2015 Sep 23. No abstract available. Erratum In: Circulation. 2016 Sep 13;134(11):e234-5.
Results Reference
background
PubMed Identifier
21817085
Citation
Kaltenbach M, Hutchinson DJ, Bollinger JE, Zhao F. Stability of diluted adenosine solutions in polyvinyl chloride infusion bags. Am J Health Syst Pharm. 2011 Aug 15;68(16):1533-6. doi: 10.2146/ajhp100573.
Results Reference
background
PubMed Identifier
9522931
Citation
Ketkar VA, Kolling WM, Nardviriyakul N, VanDer Kamp K, Wurster DE. Stability of undiluted and diluted adenosine at three temperatures in syringes and bags. Am J Health Syst Pharm. 1998 Mar 1;55(5):466-70. doi: 10.1093/ajhp/55.5.466.
Results Reference
background
PubMed Identifier
26314489
Citation
Appelboam A, Reuben A, Mann C, Gagg J, Ewings P, Barton A, Lobban T, Dayer M, Vickery J, Benger J; REVERT trial collaborators. Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial. Lancet. 2015 Oct 31;386(10005):1747-53. doi: 10.1016/S0140-6736(15)61485-4. Epub 2015 Aug 24.
Results Reference
background
PubMed Identifier
25297337
Citation
Shaker H, Jahanian F, Fathi M, Zare M. Oral verapamil in paroxysmal supraventricular tachycardia recurrence control: a randomized clinical trial. Ther Adv Cardiovasc Dis. 2015 Feb;9(1):4-9. doi: 10.1177/1753944714553425. Epub 2014 Oct 8.
Results Reference
background
Citation
10. Hayes B. Trick of the Trade: Combine Adenosine with the Flush. Available at: https://www.aliem.com/trick-of-trade-combine-adenosine-single-syringe/. Accessed March 7, 2020.
Results Reference
background
Citation
11. Weingart S. SVT: The New Hotness. Emcrit. 2015. Available at: https://emcrit.org/emcrit/new-hotnesses-for-svt/. Accessed March 7, 2020.
Results Reference
background
Citation
Choi SC, Yoon SK, Kim GW, Hur JM, Baek KW, Jung YS. A convenient method of adenosine administration for paroxysmal supraventricular tachycardia. J Korean Soc Emerg Med. 2003; 14:224-7
Results Reference
background
Citation
5. American Heart Association. ACLS for Experienced Providers Manual and Resource Text. United States of America: 2013.
Results Reference
background
PubMed Identifier
9426034
Citation
Orejarena LA, Vidaillet H Jr, DeStefano F, Nordstrom DL, Vierkant RA, Smith PN, Hayes JJ. Paroxysmal supraventricular tachycardia in the general population. J Am Coll Cardiol. 1998 Jan;31(1):150-7. doi: 10.1016/s0735-1097(97)00422-1.
Results Reference
result
Learn more about this trial
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)
We'll reach out to this number within 24 hrs