High Low Biphasic Energy Defibrillation (HiLoBED)

Ventricular Fibrillation Clinical Trial

Official title:

A Multicentre Prospective Randomised Study Comparing the Efficacy of High Versus Low Biphasic Energy Defibrillation in Patients With Cardiac Arrest

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00429611
• Other study ID #: SQCA02
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 31, 2007
• Last updated: June 30, 2009
• Start date: November 2004
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

This inhospital study aims to compare the efficacy of high-versus low-energy biphasic shocks in order to determine the optimal level for defibrillation. Time is the essence when attending to a VF patient. Hence, it is important to determine the optimal amount of defibrillation energy that should be delivered at first shock, thereby increasing the patient's chances of survival. In addition, this study provides an opportunity to evaluate the impact on myocardial integrity/function of different levels of defibrillation energy in an inhospital clinical environment.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• patients with cardiac arrest, who have a shockable rhythm (ventricular fibrillation and pulseless ventricular tachycardia)

• aged > or equal to 21 years

Exclusion Criteria:

• aged below 21 years (young patients whose ages cannot be determined accurately will not be included)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ventricular Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Singapore	Accident and Emergency Department, Changi General Hospital	Singapore
Singapore	Department of Cardiology, Tan Tock Seng Hospital	Singapore
Singapore	Department of Emergency Medicine, Singapore General Hospital	Singapore
Singapore	Division of Cardiology, Changi General Hospital	Singapore
Singapore	Division of Cardiology, National Heart Centre	Singapore
Singapore	Emergency Medicine Department, National University Hospital	Singapore
Singapore	Emergency Medicine Department, Tan Tock Seng Hospital	Singapore

Sponsors (7)

Lead Sponsor	Collaborator
Singapore General Hospital	Changi General Hospital, Medtronic, National Heart Centre Singapore, National Medical Research Council (NMRC), Singapore, National University Hospital, Singapore, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return of Spontaneous Circulation (ROSC)		First shock ROSC	Yes
Secondary	Survival at 24 hours, 7 and 30 days		24 hours after defibrillation, seven days and 30 days after admission	Yes
Secondary	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.		within 24 hours of defibrillation	Yes