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:
William Beaumont Hospitals
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
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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:
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 ]
| 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
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 May 22, 2013