Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest (PIVOT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Arrest |
Drug: Adrenaline Drug: Vasopressin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blinded Multi-centre Trial Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest at the Emergency Department. (Preadmission Intravenous Vasopressin, Adrenaline Outcome Trial: PIVOT vII) |
- Survival to Hospital Discharge. [ Time Frame: at 30 days post arrest ] [ Designated as safety issue: No ]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.
- Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. [ Time Frame: at 30 days post arrest ] [ Designated as safety issue: No ]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. [ Time Frame: at 1 year post arrest ] [ Designated as safety issue: No ]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. [ Time Frame: during resuscitation ] [ Designated as safety issue: No ]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. [ 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 727 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Adrenaline |
Drug: Adrenaline
1 mg
Other Name: Epinephrine
|
| Active Comparator: Vasopressin |
Drug: Vasopressin
40 IU
Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Singapore | |
| Singapore General Hospital | |
| Singapore, Singapore, 169608 | |
| Alexandra Hospital | |
| Singapore, Singapore, 159964 | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Changi General Hospital | |
| Singapore, Singapore, 529889 | |
| Principal Investigator: | Marcus EH Ong, MBBS | Singapore General Hospital |
More Information
No publications provided by Singapore General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marcus Ong EH, Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00358579 History of Changes |
| Other Study ID Numbers: | SQCA01 |
| Study First Received: | July 30, 2006 |
| Results First Received: | August 3, 2010 |
| Last Updated: | July 12, 2011 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by Singapore General Hospital:
|
Vasopressin Adrenaline Survival Return of spontaneous of circulation |
Additional relevant MeSH terms:
|
Heart Arrest Heart Diseases Cardiovascular Diseases Epinephrine Epinephryl borate Arginine Vasopressin Vasopressins Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Hemostatics Coagulants Hematologic Agents Antidiuretic Agents Natriuretic Agents |
ClinicalTrials.gov processed this record on June 17, 2013