Cardiac Arrest
Conditions
Keywords
Vasopressin, Adrenaline, Survival, Return of spontaneous of circulation
Brief summary
The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field. Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline.
Detailed description
The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the recommended drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field. More recently, vasopressin has been used in patients with cardiac arrest. In human studies on vasopressin, clinical trials have produced conflicting results. The current study compared vasopressin and adrenaline in the treatment of cardiac arrest in patients presenting to the Emergency Department (ED). Specific outcomes included return of spontaneous circulation (ROSC) (as measured by the presence of a palpable pulse at any time during resuscitation), survival to hospital admission, survival to discharge from hospital, and functional status at discharge and at one year (as measured by the Glasgow-Pittsburgh outcome categories).
Interventions
DRUGAdrenaline
1 mg
DRUGVasopressin
40 IU
Sponsors
National Medical Research Council (NMRC), Singapore
Alexandra Hospital
National University Hospital, Singapore
Changi General Hospital
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea * Age above 16 (Age 21 and above for CGH only)
Exclusion criteria
* Traumatic cardiac arrest * Age 16 and below (Age 20 and below for CGH only) * CPR is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival to Hospital Discharge. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | 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. |
| Neurological Status at 1 Year. | 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. |
| Return of Spontaneous Circulation. | 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. |
| Survival to Admission. | 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. |
Countries
Singapore
Participant flow
Recruitment details
The recruitment period was from 9 March 2006 to 19 January 2009. Location of recruitment was in emergency departments.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Adrenaline 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department | 353 |
| Vasopressin 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department | 374 |
| Total | 727 |
Baseline characteristics
| Characteristic | Vasopressin | Adrenaline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 188 Participants | 182 Participants | 370 Participants |
| Age, Categorical Between 18 and 65 years | 186 Participants | 170 Participants | 356 Participants |
| Age, Continuous | 64.6 years STANDARD_DEVIATION 14.2 | 64.9 years STANDARD_DEVIATION 15.4 | 64.7 years STANDARD_DEVIATION 14.8 |
| Region of Enrollment Singapore | 374 participants | 353 participants | 727 participants |
| Sex: Female, Male Female | 111 Participants | 111 Participants | 222 Participants |
| Sex: Female, Male Male | 263 Participants | 242 Participants | 505 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Survival to Hospital Discharge.
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.
Time frame: at 30 days post arrest
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adrenaline | Survival to Hospital Discharge. | 8 Participants |
| Vasopressin | Survival to Hospital Discharge. | 11 Participants |
Secondary
Neurological Status at 1 Year.
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.
Time frame: at 1 year post arrest
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adrenaline | Neurological Status at 1 Year. | Cerebral Performance Categories 1 | 5 Participants |
| Adrenaline | Neurological Status at 1 Year. | Cerebral Performance Categories 2 | 0 Participants |
| Adrenaline | Neurological Status at 1 Year. | Overall Performance Categories 1 | 3 Participants |
| Adrenaline | Neurological Status at 1 Year. | Overall Performance Categories 2 | 2 Participants |
| Vasopressin | Neurological Status at 1 Year. | Overall Performance Categories 2 | 1 Participants |
| Vasopressin | Neurological Status at 1 Year. | Cerebral Performance Categories 1 | 4 Participants |
| Vasopressin | Neurological Status at 1 Year. | Overall Performance Categories 1 | 3 Participants |
| Vasopressin | Neurological Status at 1 Year. | Cerebral Performance Categories 2 | 1 Participants |
Secondary
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.
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.
Time frame: at 30 days post arrest
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adrenaline | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Cerebral Performance Categories 1 | 5 Participants |
| Adrenaline | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Cerebral Performance Categories 2 | 0 Participants |
| Adrenaline | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Overall Performance Categories 1 | 2 Participants |
| Adrenaline | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Overall Performance Categories 2 | 3 Participants |
| Vasopressin | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Overall Performance Categories 2 | 0 Participants |
| Vasopressin | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Cerebral Performance Categories 1 | 4 Participants |
| Vasopressin | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Overall Performance Categories 1 | 5 Participants |
| Vasopressin | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. | Cerebral Performance Categories 2 | 1 Participants |
Secondary
Return of Spontaneous Circulation.
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.
Time frame: during resuscitation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adrenaline | Return of Spontaneous Circulation. | 106 Participants |
| Vasopressin | Return of Spontaneous Circulation. | 119 Participants |
Secondary
Survival to Admission.
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adrenaline | Survival to Admission. | 59 Participants |
| Vasopressin | Survival to Admission. | 83 Participants |