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Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial (Shock n Block)

This study has been terminated.
(Difficult accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401882
First Posted: November 22, 2006
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic BRC
Information provided by (Responsible Party):
David Haines, MD, William Beaumont Hospitals
  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: Epinephrine Drug: Metoprolol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by David Haines, MD, William Beaumont Hospitals:

Primary Outcome Measures:
  • Return of Spontaneous Circulation [ Time Frame: After electrical defibrillation ]
    The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.


Secondary Outcome Measures:
  • Survival to Hospital Discharge [ Time Frame: from time of arrest to discharge or death ]
    the number of patients who are alive at hospital discharge

  • Adverse Effects [ Time Frame: 30 days ]
  • Number of Precordial Shocks Required After the Administration of Metoprolol or Epinephrine [ Time Frame: 120 minutes ]
  • Total Duration of Resuscitative Efforts [ Time Frame: 120 minutes ]
  • Need for Additional Antiarrhythmic Drugs [ Time Frame: 120 minutes ]

Enrollment: 7
Study Start Date: January 2007
Study Completion Date: March 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Of Care Drug Epinephrine
Additional doses of Epinephrine (1 mg) given as part of standard of care during cardiac arrest
Drug: Epinephrine
Epinephrine (1 mg) IV additional doses
Other Name: adrenaline
Active Comparator: IV Metoprolol instead Epinephrine
IV metoprolol 5 mg. up to 2 times (only) during cardiac arrest will be given instead of additional Epinephrine doses
Drug: Metoprolol
Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses
Other Name: lopressor

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401882


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
David Haines, MD
Medtronic BRC
Investigators
Principal Investigator: David E Haines, MD William Beaumont Hospitals
  More Information

Responsible Party: David Haines, MD, Coordinator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00401882     History of Changes
Other Study ID Numbers: 2006-008
First Submitted: November 17, 2006
First Posted: November 22, 2006
Results First Submitted: July 18, 2013
Results First Posted: March 31, 2017
Last Update Posted: May 25, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by David Haines, MD, William Beaumont Hospitals:
Cardiac arrest
Sudden Cardiac Death
Ventricular Fibrillation
Pulseless Ventricular Tachycardia
Cardiopulmonary resuscitation

Additional relevant MeSH terms:
Heart Arrest
Tachycardia
Death
Death, Sudden, Cardiac
Ventricular Fibrillation
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Death, Sudden
Epinephrine
Racepinephrine
Epinephryl borate
Metoprolol
Adrenergic beta-Antagonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics


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