A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)

NCT04392362 | Completed Phase 3 Results DMC

• 1 other identifier: UPretoria
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Study to compare non inferiority of giving adenosine with the simplified method vs the AHA method

Conditions

Supra-ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• 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.

  10 seconds

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Drug: Adenosine

Control group

ACTIVE COMPARATOR

Giving adenosine Ising the recommended AHA two syringe method

Drug: Adenosine

Interventions

Adenosine DRUG

A vial of adenosine with 6mg

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Svt
• normal blood pressure
• normal mentation
• Give consent

You may not qualify if:

• recent coffee
• Allergy to adenosine
• Asthma
• cardiac operations

Sponsors & Collaborators

• University of Pretoria: lead

Study Sites (1)

Steve Biko hospital

Pretoria, Gauteng, 0001, South Africa

Location

Related Publications (12)

• 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.

  PMID: 20956224 BACKGROUND

• 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.

  PMID: 31665806 BACKGROUND

• 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.

  PMID: 26399663 BACKGROUND

• 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.

  PMID: 21817085 BACKGROUND

• 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.

  PMID: 9522931 BACKGROUND

• 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.

  PMID: 26314489 BACKGROUND

• 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.

  PMID: 25297337 BACKGROUND

• 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.

  BACKGROUND

• 11. Weingart S. SVT: The New Hotness. Emcrit. 2015. Available at: https://emcrit.org/emcrit/new-hotnesses-for-svt/. Accessed March 7, 2020.

  BACKGROUND

• 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

  BACKGROUND

• 5. American Heart Association. ACLS for Experienced Providers Manual and Resource Text. United States of America: 2013.

  BACKGROUND

• 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.

  PMID: 9426034 RESULT

MeSH Terms

Interventions

Adenosine

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Amanda Makhubela
• Organization: University of Pretoria

neurosurgeon76@gmail.com

0722746091

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomizes Control trial

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 18, 2020
• Study Start: April 1, 2018
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)