Trial Outcomes & Findings for Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest (NCT NCT00358579)

Results Overview

Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

727 participants

Primary outcome timeframe

at 30 days post arrest

Results posted on

2017-03-17

Participant Flow

The recruitment period was from 9 March 2006 to 19 January 2009. Location of recruitment was in emergency departments.

The exclusion criteria included traumatic cardiac arrest or when cardiopulmonary resuscitation was contraindicated; for example those 'obviously dead' as defined by the presence of decomposition, rigor mortis or dependant lividity. Participants below the age of 16 years old were not included in the study

Participant milestones

Participant milestones
Measure	Adrenaline 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Overall Study STARTED	353	374
Overall Study COMPLETED	353	374
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adrenaline n=353 Participants 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin n=374 Participants 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Total n=727 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	170 Participants n=5 Participants	186 Participants n=7 Participants	356 Participants n=5 Participants
Age, Categorical >=65 years	182 Participants n=5 Participants	188 Participants n=7 Participants	370 Participants n=5 Participants
Age, Continuous	64.9 years STANDARD_DEVIATION 15.4 • n=5 Participants	64.6 years STANDARD_DEVIATION 14.2 • n=7 Participants	64.7 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	111 Participants n=7 Participants	222 Participants n=5 Participants
Sex: Female, Male Male	242 Participants n=5 Participants	263 Participants n=7 Participants	505 Participants n=5 Participants
Region of Enrollment Singapore	353 participants n=5 Participants	374 participants n=7 Participants	727 participants n=5 Participants

PRIMARY outcome

Timeframe: at 30 days post arrest

Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.

Outcome measures

Outcome measures
Measure	Adrenaline n=353 Participants 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin n=374 Participants 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Survival to Hospital Discharge.	8 Participants	11 Participants

SECONDARY outcome

Timeframe: at 30 days post arrest

Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral \& overall performance. CPC/OPC 2 indicates moderate cerebral \& overall disability. CPC/OPC 3 indicates severe cerebral \& overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.

Outcome measures

Outcome measures
Measure	Adrenaline n=353 Participants 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin n=374 Participants 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. Cerebral Performance Categories 1	5 Participants	4 Participants
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. Cerebral Performance Categories 2	0 Participants	1 Participants
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. Overall Performance Categories 1	2 Participants	5 Participants
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. Overall Performance Categories 2	3 Participants	0 Participants

SECONDARY outcome

Timeframe: at 1 year post arrest

Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral \& overall performance. CPC/OPC 2 indicates moderate cerebral \& overall disability. CPC/OPC 3 indicates severe cerebral \& overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.

Outcome measures

Outcome measures
Measure	Adrenaline n=353 Participants 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin n=374 Participants 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Neurological Status at 1 Year. Cerebral Performance Categories 1	5 Participants	4 Participants
Neurological Status at 1 Year. Cerebral Performance Categories 2	0 Participants	1 Participants
Neurological Status at 1 Year. Overall Performance Categories 1	3 Participants	3 Participants
Neurological Status at 1 Year. Overall Performance Categories 2	2 Participants	1 Participants

SECONDARY outcome

Timeframe: during resuscitation

Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation.

Outcome measures

Outcome measures
Measure	Adrenaline n=353 Participants 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin n=374 Participants 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Return of Spontaneous Circulation.	106 Participants	119 Participants

SECONDARY outcome

Timeframe: No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards

Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital.

Outcome measures

Outcome measures
Measure	Adrenaline n=353 Participants 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department	Vasopressin n=374 Participants 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Survival to Admission.	59 Participants	83 Participants

Adverse Events

Adrenaline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vasopressin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

A/Prof Marcus Ong Eng Hock

Singapore General Hospital

Phone: +6563213590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place