Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial - Full Text View

Sponsor:	William Beaumont Hospitals
Collaborator:	Medtronic BRC
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00401882

Purpose

The purpose of this research study is to evaluate the effectiveness of metoprolol, a "beta blocker," in treating patients in the hospital with a cardiac arrest. It will be given intravenously (given into a vein). The subjects who will take part in this study are 18 years of age or older, are experiencing a cardiac arrest in the hospital, and are in a life threatening situation. Patients who develop a cardiac arrest require prompt electrical defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In patients who do not respond to electrical defibrillation, current standard of care recommends the use of medications which have been shown to be of unknown benefit. Some people recover from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol will improve survival of patients with a cardiac arrest. A total of 100 patients will be enrolled in the study. Patients will receive either the standard of care with the drug epinephrine or the standard of care plus metoprolol.

Condition	Intervention	Phase
Cardiac Arrest Sudden Cardiac Death Ventricular Fibrillation Tachycardia, Ventricular	Drug: Metoprolol	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia short QT syndrome

MedlinePlus related topics: Cardiac Arrest Shock

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

Return of spontaneous circulation [ Time Frame: After each electrical defibrillation ] [ Designated as safety issue: Yes ]
The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.

Secondary Outcome Measures:

Survival to hospital discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Adverse effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Number of precordial shocks required after the administration of metoprolol or epinephrine [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
Total duration of resuscitative efforts [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
Need for additional antiarrhythmic drugs [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Intervention Details:

IV metoprolol will be administrated instead of additional doses of epinephrine.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients age > 18 years of age who develop an in-hospital VF or pVT arrest which persists after three or more precordial shocks.
Patients who develop an in-hospital cardiac arrest due to asystole or PEA which subsequently converts to VF or pVT will be included.

Exclusion Criteria:

Pediatric patients
Pregnancy
Age < 18 years of age
Patients who develop VF or pVT in the emergency room, operating room or surgical intensive care unit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401882

Contacts

Contact: David Haines, MD

248-898-4198

dhaines@beaumont.edu

Locations

United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: David Haines, MD 248-898-4198 dhaines@beaumont.edu
Principal Investigator: david Haines, MD

Sponsors and Collaborators

William Beaumont Hospitals

Medtronic BRC

Investigators

Principal Investigator:

David E Haines, MD

William Beaumont Hospitals

More Information

No publications provided

Responsible Party:	David Haines, Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00401882 History of Changes
Other Study ID Numbers:	2006-008
Study First Received:	November 17, 2006
Last Updated:	July 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

Cardiac arrest
Sudden Cardiac Death
Ventricular Fibrillation
Pulseless Ventricular Tachycardia
Cardiopulmonary resuscitation

Additional relevant MeSH terms:

Death
Heart Arrest
Shock
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Death, Sudden, Cardiac
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Death, Sudden
Adrenergic beta-Antagonists
Metoprolol
Metoprolol succinate

Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012