Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT
Primary Purpose
Supraventricular Tachycardia
Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Calcium Channel Blocker & Adenosine
Sponsored by
About this trial
This is an interventional treatment trial for Supraventricular Tachycardia focused on measuring Supraventricular Tachycardia, Calcium Channel Blockers, Verapamil, Diltiazem, Adenosine
Eligibility Criteria
Inclusion Criteria:
- More than 10 years old
- Electrocardiographic diagnosis of SVT
- SVT not converted by the vagal manoeuvres
Exclusion Criteria:
- Signs of impaired cerebral perfusion
- Signs of pulmonary oedema
- Subsequent diagnosis of other types of arrythmias rather than SVT
- pregnancy by history
Sites / Locations
- Singapore General Hospital
Outcomes
Primary Outcome Measures
Conversion to the sinus rhythm.
Secondary Outcome Measures
Recurrence of SVT
Stability of vital signs
Full Information
NCT ID
NCT00413712
First Posted
December 19, 2006
Last Updated
February 9, 2017
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00413712
Brief Title
Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT
Official Title
Comparism Between Efficacy and Effectiveness Between Slow Infusion of Calcium Channel Blockers and Intravenous Bolus Adenosine in the Management of Supraventricular Tachycardia in the Emergency Department.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia.
Detailed Description
Paroxysmal Supraventricular Tachycardia (SVT) is a common cardiac emergency encountered in the Emergency Department. Both Calcium Channel Blockers (CCB) and Adenosine have been using in the Management of SVT.
Objective
This study compared the efficacy and effectiveness between slow Infusion of Calcium Channel Blockers (either Verapamil or Diltiazem) and bolus intravenous Adenosine in termination of SVT.
Methodology
This was a prospective, randomised, controlled clinical trial comparing the efficacy and effects of intravenous adenosine with slow infusion of calcium channel blockers (verapamil or diltiazem) in patients presenting with SVT to an Emergency Department. The study was approved by the hospital's Ethics Committee.
Patients of at least 10 years of age, who presented to the Emergency Department of the Singapore General Hospital with regular narrow complex tachycardia and an electrocardiographic(ECG) diagnosis of SVT that was not converted by vagal manoeuvres (Valsava manoeuvre or carotid sinus massage or both) and who were in SVT at the time of doctor attendance were included in the study.
The exclusion criteria were as follows:
Patients with signs of impaired cerebral perfusion (e.g. altered mental state) or acute pulmonary oedema
Patients with a subsequent diagnosis of arrhythmias other than SVT (i.e. sinus tachycardia, atrial flutter, atrial fibrillation or idiopathic ventricular tachycardia) were excluded from the analysis if they were initially enrolled
Pregnancy by history (urine pregnancy testing was not used to actively exclude the condition in any of the female patients entered into the study).
Having selected the patients according to the criteria, they were randomly assigned into two groups: one to receive calcium channel blockers and the other, Adenosine. Within the former group, some were assigned randomly to receive Diltiazem and some to Verapamil.
Diltiazem was given at the dose of 2.5mg per minute (4ml per minute of a concentration of 0.625 mg/ml) up to a maximum of 50 mg. The dose of Verapamil was 1mg per minute (4ml per minute of a concentration of 0.25mg/ml) up to a maximum of 20mg. Both were given as a slow intravenous infusion using a Terumo infusion pump.
During intravenous infusion, the patient's vital signs, viz. heart rate and systolic and diastolic blood pressures, were monitored at two-minute intervals up to completion of infusion or conversion from SVT, whichever was the earlier. At the time of conversion to sinus rhythm, the infusion was stopped and the amount of drug infused was noted and recorded.
Regarding the Adenosine group, all the patients were administered Adenosine as a rapid bolus within 2 sec through an 18G IV cannula at an antecubital vein, followed by 10 ml saline flush and elevation of the limb. Initially 6ml bolus was given rapidly, and if there was no conversion of the SVT within 2 min, another 12 mg bolus was administered.
If SVT was not converted at the end of any of calcium channel blocker infusion, those patients were then given intravenous Adenosine as described above. Similarly, those patients who remained in SVT after first two initial boluses of Adenosine were again randomized to receive either Verapamil or Diltiazem.
This allowed four orders of treatment as follows:
Verapamil infusion followed by Adenosine
Diltiazem infusion followed by Adenosine
Adenosine followed by Verapamil infusion
Adenosine followed by Diltiazem infusion
If the tachycardia was not converted at the end of the study protocol, patients were managed either with synchronised electrical cardioversion if haemodynamically unstable or with further pharmacotherapy at the discretion of the treating physician if vital signs were stable.
Following the successful conversion, patients' vital signs were closely monitored at 1 min (immediate post-conversion), 5,10, 15 min and finally 30 min of post-conversion. If they remained stable, they were shifted to observation ward with continuous telemetric monitoring. They were eventually discharged if there were no recurrence during the period of observation and arranged a follow-up appointment at Arrhythmia Clinic one week later. Patients with the recurrence of SVT during the two-hour observation period were managed at the discretion of the treating physician.
Study end points were as follows:
Conversion to sinus rhythm
Withdrawal because of major adverse effects
Completion of trial protocol without termination of tachycardia
Data on the final analysis was obtained from follow-up records of Cardiology department as well. The cost of medication used for each patient was also computed to understand the cost aspects of different regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia
Keywords
Supraventricular Tachycardia, Calcium Channel Blockers, Verapamil, Diltiazem, Adenosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calcium Channel Blocker & Adenosine
Primary Outcome Measure Information:
Title
Conversion to the sinus rhythm.
Secondary Outcome Measure Information:
Title
Recurrence of SVT
Title
Stability of vital signs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 10 years old
Electrocardiographic diagnosis of SVT
SVT not converted by the vagal manoeuvres
Exclusion Criteria:
Signs of impaired cerebral perfusion
Signs of pulmonary oedema
Subsequent diagnosis of other types of arrythmias rather than SVT
pregnancy by history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lim S Han, MBBS,FRCS
Organizational Affiliation
Department of Emergency Medicine, Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
62223322
Country
Singapore
12. IPD Sharing Statement
Citations:
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Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT
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