Supra-ventricular Tachycardia
Conditions
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
Interventions
DRUGAdenosine
A vial of adenosine with 6mg
Sponsors
University of Pretoria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomizes Control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Svt * normal blood pressure * normal mentation * Give consent
Exclusion criteria
* recent coffee * Allergy to adenosine * Asthma * cardiac operations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 10 seconds | The primary outcome is the rhythm of conversion to a sinus rhythm less than 140 beat per minute. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| AHA Method Giving adenosine Ising the recommended AHA two syringe method
Adenosine: A vial of adenosine with 6mg | 7 |
| Total | 30 |
Baseline characteristics
| Characteristic | Simplified Method | AHA Method | Total |
|---|---|---|---|
| Age, Customized 18-59 years | 16 Participants | 5 Participants | 21 Participants |
| Age, Customized 60-80 years | 7 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 9 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Race Black or African American | 13 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) Race More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 23 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Female | 18 Participants | 5 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 7 |
| other Total, other adverse events | 23 / 23 | 7 / 7 |
| serious Total, serious adverse events | 0 / 23 | 0 / 7 |
Outcome results
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.
Time frame: 10 seconds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | 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 | 13 participants |
| Control Group | 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 | 4 participants |
Comparison: The null hypothesis is that the AHA method is inferior to the SIM method but not lower than a pre calculated noninferiority delta of -0.12 (-12 %) and a 95% one sided confidence interval. Only 33 (instead of 151 for a power of 95%) patients could be enrolled with 25 in the SIM and 8 in the AHA arms, which resulted in an estimated power test of 59.08%.p-value: 0.8982Wilcoxon (Mann-Whitney)