search
Back to results

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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Adrenaline
Vasopressin
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Vasopressin, Adrenaline, Survival, Return of spontaneous of circulation

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University Hospital
  • Alexandra Hospital
  • Singapore General Hospital
  • Changi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Adrenaline

Vasopressin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 30, 2006
Last Updated
February 9, 2017
Sponsor
Singapore General Hospital
Collaborators
National Medical Research Council (NMRC), Singapore, Alexandra Hospital, National University Hospital, Singapore, Changi General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00358579
Brief Title
Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest
Acronym
PIVOT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
National Medical Research Council (NMRC), Singapore, Alexandra Hospital, National University Hospital, Singapore, Changi General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Vasopressin, Adrenaline, Survival, Return of spontaneous of circulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
727 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adrenaline
Arm Type
Active Comparator
Arm Title
Vasopressin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Other Intervention Name(s)
Epinephrine
Intervention Description
1 mg
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Other Intervention Name(s)
Arginine vasopressin, argipressin, antidiuretic hormone
Intervention Description
40 IU
Primary Outcome Measure Information:
Title
Survival to Hospital Discharge.
Description
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
Secondary Outcome Measure Information:
Title
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.
Description
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
Title
Neurological Status at 1 Year.
Description
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
Title
Return of Spontaneous Circulation.
Description
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
Title
Survival to Admission.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus EH Ong, MBBS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Alexandra Hospital
City
Singapore
ZIP/Postal Code
159964
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
22353644
Citation
Ong ME, Tiah L, Leong BS, Tan EC, Ong VY, Tan EA, Poh BY, Pek PP, Chen Y. A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department. Resuscitation. 2012 Aug;83(8):953-60. doi: 10.1016/j.resuscitation.2012.02.005. Epub 2012 Feb 18.
Results Reference
derived

Learn more about this trial

Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest

We'll reach out to this number within 24 hrs