High Low Biphasic Energy Defibrillation (HiLoBED)

June 30, 2009 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Ventricular Fibrillation

Intervention / Treatment

Procedure: Cardiac defibrillation at high energy vs low energy levels

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Singapore
- - Singapore, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Return of Spontaneous Circulation (ROSC) Time Frame: First shock ROSC	First shock ROSC

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival at 24 hours, 7 and 30 days Time Frame: 24 hours after defibrillation, seven days and 30 days after admission	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	within 24 hours of defibrillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

National University Hospital, Singapore

Tan Tock Seng Hospital

Medtronic

Changi General Hospital

National Heart Centre Singapore

National Medical Research Council (NMRC), Singapore

Investigators

Principal Investigator: V Anantharaman, MBBS, Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria