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Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest (PIVOT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00358579
First Posted: August 1, 2006
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Medical Research Council (NMRC), Singapore
Alexandra Hospital, Singapore
National University Hospital, Singapore
Changi General Hospital
Information provided by (Responsible Party):
Singapore General Hospital
  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
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)

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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:
  • Arginine vasopressin
  • argipressin
  • antidiuretic hormone

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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


Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Alexandra Hospital
Singapore, Singapore, 159964
Singapore General Hospital
Singapore, Singapore, 169608
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Singapore General Hospital
National Medical Research Council (NMRC), Singapore
Alexandra Hospital, Singapore
National University Hospital, Singapore
Changi General Hospital
Investigators
Principal Investigator: Marcus EH Ong, MBBS Singapore General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00358579     History of Changes
Other Study ID Numbers: SQCA01
First Submitted: July 30, 2006
First Posted: August 1, 2006
Results First Submitted: August 3, 2010
Results First Posted: August 9, 2011
Last Update Posted: March 17, 2017
Last Verified: February 2017

Keywords provided by Singapore General Hospital:
Vasopressin
Adrenaline
Survival
Return of spontaneous of circulation

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Vasopressins
Arginine Vasopressin
Epinephrine
Racepinephrine
Epinephryl borate
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
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