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

NCT00401882 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2006-008
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest; Sudden Cardiac Death; Ventricular Fibrillation; Tachycardia, Ventricular

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Return of Spontaneous Circulation

  The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.

  After electrical defibrillation

Secondary Outcomes (5)

• Survival to Hospital Discharge

  from time of arrest to discharge or death

• Adverse Effects

  30 days

• Number of Precordial Shocks Required After the Administration of Metoprolol or Epinephrine

  120 minutes

• Total Duration of Resuscitative Efforts

  120 minutes

• Need for Additional Antiarrhythmic Drugs

  120 minutes

Study Arms (2)

Standard Of Care Drug Epinephrine

ACTIVE COMPARATOR

Additional doses of Epinephrine (1 mg) given as part of standard of care during cardiac arrest

Drug: Epinephrine

IV Metoprolol instead Epinephrine

ACTIVE COMPARATOR

IV metoprolol 5 mg. up to 2 times (only) during cardiac arrest will be given instead of additional Epinephrine doses

Drug: Metoprolol

Interventions

Epinephrine DRUG

Epinephrine (1 mg) IV additional doses

Also known as: adrenaline

Standard Of Care Drug Epinephrine

Metoprolol DRUG

Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses

Also known as: lopressor

IV Metoprolol instead Epinephrine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Haines, MD: lead
• Medtronic BRC: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular

Interventions

Epinephrine; Metoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenoxypropanolamines; Propanolamines; Propanols

Limitations and Caveats

Early termination secondary to poor enrollment

Results Point of Contact

• Title: David Haines, MD
• Organization: Beaumont

david.haines@beaumont.edu

248-898-4198

Study Officials

• David E Haines, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: January 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 25, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-03

Locations

US (1)