High Low Biphasic Energy Defibrillation (HiLoBED)
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|ClinicalTrials.gov Identifier: NCT00429611|
Recruitment Status : Unknown
Verified June 2009 by Singapore General Hospital.
Recruitment status was: Active, not recruiting
First Posted : February 1, 2007
Last Update Posted : July 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Fibrillation||Procedure: Cardiac defibrillation at high energy vs low energy levels||Phase 3|
This is a prospective, randomised study to be conducted in the Emergency Medicine Departments and Cardiology Departments of four major hospitals, viz. Singapore General Hospital, National University Hospital, Changi General Hospital and Tan Tock Seng Hospital. The four hospitals were selected as they generally handle the most patients experiencing ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT) in the inhospital setting in this country. The study will include patients with cardiac arrest, who have a shockable rhythm (VF and pulseless VT) and aged 21 years and above. Patients who have received defibrillation pre-hospital will also be included if they are still in VF at time of arrival at the hospital.
Patients will be administered one of the following:
- Defibrillation with progressive high-energy biphasic shocks using the Medtronic Physio-Control LifePak 12 at 200J, 300J and 360J. If still unsuccessful, further shocks at 360J plus anti-arrhythmics as per American Heart Association (AHA) and Singapore National Resuscitation Council (NRC) guidelines for mega VF will be applied.
- Defibrillation with low-energy biphasic shocks using the Medtronic Physio- Control LifePak 12 at 150J, 150J and 150J. If still unsuccessful, shocks will be continued at the higher energy range (as above) plus the use of anti- arrhythmics as per the AHA and NRC guidelines for mega VF.
Results will be analysed to obtain first/subsequent shock defibrillation efficacy and post-shock myocardial function/dysfunction. This randomised study is the first of its kind to explore the efficacy of different biphasic energy levels and their impact on myocardial integrity/function in an inhospital clinical setting. After completion, the study will be expected to produce at least Level 2 results, which would be useful to international resuscitation committees in determining future guidelines and recommendations for defirillation in cardiac arrest victims.
At the conclusion of the study, the results will be analysed and published as soon as possible. This will be the responsibility of the Principal Investigator.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicentre Prospective Randomised Study Comparing the Efficacy of High Versus Low Biphasic Energy Defibrillation in Patients With Cardiac Arrest|
|Study Start Date :||November 2004|
|Estimated Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||December 2009|
- Procedure: Cardiac defibrillation at high energy vs low energy levels
Defibrillation with progressive high-energy biphasic shocks at 200J, 300J and 360J or low-energy biphasic shocks at 150J, 150J and 150J.
- Return of Spontaneous Circulation (ROSC) [ Time Frame: First shock ROSC ]
- Survival at 24 hours, 7 and 30 days [ Time Frame: 24 hours after defibrillation, seven days and 30 days after admission ]
- Myocardial damage/dysfunction as indicated by ST segment elevation/depression (mm) at 1 minute, 10 minutes and 24 hours, highest CKMB level and LVEF by echocardiography. [ Time Frame: within 24 hours of defibrillation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429611
|Accident and Emergency Department, Changi General Hospital|
|Department of Cardiology, Tan Tock Seng Hospital|
|Department of Emergency Medicine, Singapore General Hospital|
|Division of Cardiology, Changi General Hospital|
|Division of Cardiology, National Heart Centre|
|Emergency Medicine Department, National University Hospital|
|Emergency Medicine Department, Tan Tock Seng Hospital|
|Principal Investigator:||V Anantharaman, MBBS||Singapore General Hospital|