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:
Collaborator:
Medtronic BRC
Information provided by (Responsible Party):
Lihua QU, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00401882
First received: November 17, 2006
Last updated: September 19, 2012
Last verified: September 2012
  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 2

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:


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 ]

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
no arms for this study Drug: Metoprolol
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
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: NCT00401882

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
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: Lihua QU, Coordinator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00401882     History of Changes
Other Study ID Numbers: 2006-008
Study First Received: November 17, 2006
Last Updated: September 19, 2012
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 August 20, 2014