Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest (PIVOT)
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| ClinicalTrials.gov Identifier: NCT00358579 |
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Recruitment Status :
Completed
First Posted : August 1, 2006
Results First Posted : August 9, 2011
Last Update Posted : March 17, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Arrest | Drug: Adrenaline Drug: Vasopressin | Phase 3 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 727 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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) |
| Study Start Date : | March 2006 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2010 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Adrenaline |
Drug: Adrenaline
1 mg
Other Name: Epinephrine |
| Active Comparator: Vasopressin |
Drug: Vasopressin
40 IU
Other Names:
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- Survival to Hospital Discharge. [ Time Frame: 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.
- Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ 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 ]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.
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| Ages Eligible for Study: | 17 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358579
| Singapore | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Alexandra Hospital | |
| Singapore, Singapore, 159964 | |
| Singapore General Hospital | |
| Singapore, Singapore, 169608 | |
| Changi General Hospital | |
| Singapore, Singapore, 529889 | |
| Principal Investigator: | Marcus EH Ong, MBBS | Singapore General Hospital |
| Responsible Party: | Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00358579 |
| Other Study ID Numbers: |
SQCA01 |
| First Posted: | August 1, 2006 Key Record Dates |
| Results First Posted: | August 9, 2011 |
| Last Update Posted: | March 17, 2017 |
| Last Verified: | February 2017 |
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Vasopressin Adrenaline Survival Return of spontaneous of circulation |
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Heart Arrest Heart Diseases Cardiovascular Diseases Vasopressins Arginine Vasopressin Epinephrine Racepinephrine Epinephryl borate Physiological Effects of Drugs Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents Hemostatics Coagulants Antidiuretic Agents Natriuretic Agents |