High Low Biphasic Energy Defibrillation (HiLoBED)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Singapore General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
Medtronic
National Heart Centre of Singapore Pte Ltd
Tan Tock Seng Hospital
Changi General Hospital
National University Hospital, Singapore
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00429611
First received: January 31, 2007
Last updated: June 30, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Ventricular Fibrillation
Procedure: Cardiac defibrillation at high energy vs low energy levels
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multicentre Prospective Randomised Study Comparing the Efficacy of High Versus Low Biphasic Energy Defibrillation in Patients With Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Return of Spontaneous Circulation (ROSC) [ Time Frame: First shock ROSC ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival at 24 hours, 7 and 30 days [ Time Frame: 24 hours after defibrillation, seven days and 30 days after admission ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: November 2004
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429611

Locations
Singapore
Department of Cardiology, Tan Tock Seng Hospital
Singapore, Singapore
Emergency Medicine Department, Tan Tock Seng Hospital
Singapore, Singapore
Accident and Emergency Department, Changi 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
Department of Emergency Medicine, Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
National Medical Research Council (NMRC), Singapore
Medtronic
National Heart Centre of Singapore Pte Ltd
Tan Tock Seng Hospital
Changi General Hospital
National University Hospital, Singapore
Investigators
Principal Investigator: V Anantharaman, MBBS Singapore General Hospital
  More Information

No publications provided

Responsible Party: Prof. V. Anantharaman, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00429611     History of Changes
Other Study ID Numbers: SQCA02
Study First Received: January 31, 2007
Last Updated: June 30, 2009
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
biphasic defibrillation
inhospital
post-resuscitation myocardial function
defibrillation efficacy
high energy versus low energy
cardiac arrest patients

Additional relevant MeSH terms:
Heart Arrest
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014