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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 19, 2006 | ||||
| Last Updated Date | December 19, 2006 | ||||
| Start Date ICMJE | January 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Conversion to the sinus rhythm. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT | ||||
| Official Title ICMJE | 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. | ||||
| 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. |
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| 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:
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:
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:
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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Supraventricular Tachycardia | ||||
| Intervention ICMJE | Drug: Calcium Channel Blocker & Adenosine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 206 | ||||
| Completion Date | March 2001 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00413712 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | IRB18/1997 | ||||
| Study Sponsor ICMJE | Singapore General Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Singapore General Hospital | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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