Trial Outcomes & Findings for Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial (NCT NCT00401882)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

After electrical defibrillation

Results posted on

2017-05-25

Participant Flow

Patients in the ventricular tacchycardia refractory to shock with beta blocker

After the patient was refractory to treatment of the Epinephrine the patient would receive medication called Metroprolol

Participant milestones

Participant milestones
Measure	Additional Doses of Epinephrine Epinephrine: additional doses Epinephrine (1 mg) IV given as part of standard of care in cardiac arrest	Metoprolol Instead of Additional Epinephrine Doses Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional doses of epinephrine
Overall Study STARTED	2	5
Overall Study COMPLETED	2	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Additional Epinephrine Doses n=2 Participants Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest	Metoprolol n=5 Participants Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	68.5 years STANDARD_DEVIATION 21.9 • n=5 Participants	60.8 years STANDARD_DEVIATION 5.49 • n=7 Participants	63 years STANDARD_DEVIATION 10.69 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: After electrical defibrillation

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

Outcome measures

Outcome measures
Measure	Additional Epinephrine Doses n=2 Participants Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest	Metoprolol n=5 Participants Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
Return of Spontaneous Circulation	0 Participants	1 Participants

SECONDARY outcome

Timeframe: from time of arrest to discharge or death

the number of patients who are alive at hospital discharge

Outcome measures

Outcome measures
Measure	Additional Epinephrine Doses n=2 Participants Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest	Metoprolol n=5 Participants Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
Survival to Hospital Discharge	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Additional Epinephrine Doses n=2 Participants Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest	Metoprolol n=5 Participants Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
Adverse Effects	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 120 minutes

Population: Data point not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 minutes

Population: Data point not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 minutes

Population: Data point not analyzed

Outcome measures

Outcome data not reported

Adverse Events

Additional Doses of Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Metoprolol Instead of Additional Doses of Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Haines, MD

Beaumont

Phone: 248-898-4198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place