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

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ClinicalTrials.gov Identifier: NCT00401882
Recruitment Status : Terminated (Difficult accrual)
First Posted : November 22, 2006
Results First Posted : March 31, 2017
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
Medtronic BRC
Information provided by (Responsible Party):
David Haines, MD, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cardiac Arrest
Sudden Cardiac Death
Ventricular Fibrillation
Tachycardia, Ventricular
Interventions Drug: Epinephrine
Drug: Metoprolol
Enrollment 7
Recruitment Details Patients in the ventricular tacchycardia refractory to shock with beta blocker
Pre-assignment Details After the patient was refractory to treatment of the Epinephrine the patient would receive medication called Metroprolol
Arm/Group Title Additional Doses of Epinephrine Metoprolol Instead of Additional Epinephrine Doses
Hide Arm/Group Description Epinephrine: additional doses Epinephrine (1 mg) IV given as part of standard of care in cardiac arrest Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional doses of epinephrine
Period Title: Overall Study
Started 2 5
Completed 2 5
Not Completed 0 0
Arm/Group Title Additional Epinephrine Doses Metoprolol Total
Hide Arm/Group Description Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest Total of all reporting groups
Overall Number of Baseline Participants 2 5 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 5 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
4
  80.0%
5
  71.4%
>=65 years
1
  50.0%
1
  20.0%
2
  28.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 5 participants 7 participants
68.5  (21.9) 60.8  (5.49) 63  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 5 participants 7 participants
Female
1
  50.0%
1
  20.0%
2
  28.6%
Male
1
  50.0%
4
  80.0%
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 5 participants 7 participants
2 5 7
1.Primary Outcome
Title Return of Spontaneous Circulation
Hide Description The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.
Time Frame After electrical defibrillation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Additional Doses of Epinephrine Metoprolol Instead of Additional Epinephrine Doses
Hide Arm/Group Description:
Epinephrine: Additional doses of epinephrine (1 mg IV) given as part of standard of care during cardiac arrest
Metoprolol 5 mg IV (up to 2 times) instead of additional epinephrine doses
Overall Number of Participants Analyzed 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  20.0%
2.Secondary Outcome
Title Survival to Hospital Discharge
Hide Description the number of patients who are alive at hospital discharge
Time Frame from time of arrest to discharge or death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Additional Epinephrine Doses Metoprolol Instead of Additional Epinephrine Doses
Hide Arm/Group Description:

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

Epinephrine: Epinephrine (1 mg) IV additional doses

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

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

Overall Number of Participants Analyzed 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Adverse Effects
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Additional Doses of Epinephrine Metoprolol Instead of Additional Epinephrine Doses
Hide Arm/Group Description:
Epinephrine: Additional doses of epinephrine IV (1 mg) given as part of standard of care in cardiac arrest
Metoprolol: Metoprolol 5mg IV (up to two times only) instead of additional epinephrine doses
Overall Number of Participants Analyzed 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Precordial Shocks Required After the Administration of Metoprolol or Epinephrine
Hide Description [Not Specified]
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Data point not analyzed
Arm/Group Title Additional Epinephrine Doses Metoprolol
Hide Arm/Group Description:
Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Total Duration of Resuscitative Efforts
Hide Description [Not Specified]
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Data point not analyzed
Arm/Group Title Additional Epinephrine Doses Metoprolol
Hide Arm/Group Description:
Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Need for Additional Antiarrhythmic Drugs
Hide Description [Not Specified]
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Data point not analyzed
Arm/Group Title Additional Epinephrine Doses Metoprolol
Hide Arm/Group Description:
Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame After Electrical Defibrillation, up to 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Additional Doses of Epinephrine Metoprolol Instead of Additional Doses of Epinephrine
Hide Arm/Group Description Epinephrine: Additional doses epinephrine (1 mg IV) as part of standard of care during cardiac arrest Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional epinephrine doses
All-Cause Mortality
Additional Doses of Epinephrine Metoprolol Instead of Additional Doses of Epinephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   5/5 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Additional Doses of Epinephrine Metoprolol Instead of Additional Doses of Epinephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Additional Doses of Epinephrine Metoprolol Instead of Additional Doses of Epinephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/5 (0.00%) 
Early termination secondary to poor enrollment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Haines, MD
Organization: Beaumont
Phone: 248-898-4198
EMail: david.haines@beaumont.edu
Layout table for additonal information
Responsible Party: David Haines, MD, 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