High Low Biphasic Energy Defibrillation (HiLoBED)

NCT00429611 | Unknown Phase 3 DMC

• 1 other identifier: SQCA02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Ventricular Fibrillation

Keywords

biphasic defibrillation; inhospital; post-resuscitation myocardial function; defibrillation efficacy; high energy versus low energy; cardiac arrest patients

Outcome Measures

Primary Outcomes (1)

• Return of Spontaneous Circulation (ROSC)

  First shock ROSC

Secondary Outcomes (2)

• Survival at 24 hours, 7 and 30 days

  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.

  within 24 hours of defibrillation

Interventions

Cardiac defibrillation at high energy vs low energy levels PROCEDURE

Defibrillation with progressive high-energy biphasic shocks at 200J, 300J and 360J or low-energy biphasic shocks at 150J, 150J and 150J.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with cardiac arrest, who have a shockable rhythm (ventricular fibrillation and pulseless ventricular tachycardia)
• aged \> or equal to 21 years

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Medtronic: collaborator
• National Heart Centre Singapore: collaborator
• Tan Tock Seng Hospital: collaborator
• Changi General Hospital: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (7)

Accident and Emergency Department, Changi General Hospital

Singapore, Singapore

Location

Department of Cardiology, Tan Tock Seng Hospital

Singapore, Singapore

Location

Department of Emergency Medicine, Singapore General Hospital

Singapore, Singapore

Location

Division of Cardiology, Changi General Hospital

Singapore, Singapore

Location

Division of Cardiology, National Heart Centre

Singapore, Singapore

Location

Emergency Medicine Department, National University Hospital

Singapore, Singapore

Location

Emergency Medicine Department, Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• V Anantharaman, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: November 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 2, 2009

Record last verified: 2009-06

Locations

SG (7)