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Study to compare non inferiority of giving adenosine with the simplified method vs the AHA method
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | Active Comparator | Giving adenosine Ising the recommended AHA two syringe method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine | Drug | A vial of adenosine with 6mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steve Biko hospital | Pretoria | Gauteng | 0001 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20956224 | Background | 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. | |
| 31665806 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention/SIM Group | Giving adenosine 6mg premixed with saline flush to a total of 20ml and giving it as a rapid flush, then same method repeated twice with 12 mg adenosine if the SVT does not convert The group evaluated was the SIM or intervention group |
| FG001 | Control/AHA Group | Giving adenosine as 6mg in one syringe with a separate syringe with 20ml saline flush using a three way stop cock to connect the syringes. Adenosine is given first as a rapid push followed by another rapid flush from the saline. The same method to be repeated twice with 12 mg adenosine if the SVT does not convert after 10-15 seconds The group evaluated was the AHA or control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simplified Method | 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 Adenosine: A vial of adenosine with 6mg |
| BG001 | AHA Method |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 10 seconds |
|
2 hours
There were no major adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Adenosine: A vial of adenosine with 6mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling of impending doom, dizziness | Cardiac disorders | Systematic Assessment | Feeling of impending doom, dizziness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Makhubela | University of Pretoria | 0722746091 | neurosurgeon76@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Jun 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Randomizes Control trial
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| 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. |
| 26399663 | 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. |
| 21817085 | 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. |
| 9522931 | 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. |
| 26314489 | 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. |
| 25297337 | 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. |
| 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. |
| 9426034 | Result | 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. |
Giving adenosine Ising the recommended AHA two syringe method Adenosine: A vial of adenosine with 6mg |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Patients were male or female | Count of Participants | Participants |
|
| Race (NIH/OMB) | The races were African, Asian, Coloured | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 23 |
| 23 |
| EG001 | Control Group | Giving adenosine Ising the recommended AHA two syringe method Adenosine: A vial of adenosine with 6mg | 0 | 7 | 0 | 7 | 7 | 7 |
|
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| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |