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

NCT ID: NCT04392362

Last Updated: 2021-06-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Supra-ventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomizes Control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

A vial of adenosine with 6mg

Control group

Giving adenosine Ising the recommended AHA two syringe method

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

A vial of adenosine with 6mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adenosine

A vial of adenosine with 6mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Svt
* normal blood pressure
* normal mentation
* Give consent

Exclusion Criteria

* recent coffee
* Allergy to adenosine
* Asthma
* cardiac operations
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pretoria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amanda Makhubela, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Steve Biko hospital

Pretoria, Gauteng, South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Africa

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20956224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31665806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26399663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21817085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9522931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26314489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25297337 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type 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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type RESULT
PMID: 9426034 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UPretoria

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outcome of SVT in Children Admitted to AUCH
NCT07143591 NOT_YET_RECRUITING
Differentiate AVNRT from Orthodromic AVRT
NCT06671145 NOT_YET_RECRUITING NA