Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest
Information source: Singapore General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Arrest
Intervention: Adrenaline (Drug); Vasopressin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Singapore General Hospital Official(s) and/or principal investigator(s): Marcus EH Ong, MBBS, Principal Investigator, Affiliation: Singapore General Hospital
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Survival to Hospital Discharge.
Secondary outcome: Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.Neurological Status at 1 Year. Return of Spontaneous Circulation. Survival to Admission.
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
Minimum age: 17 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Alexandra Hospital, Singapore 159964, Singapore
Changi General Hospital, Singapore 529889, Singapore
National University Hospital, Singapore 119074, Singapore
Singapore General Hospital, Singapore 169608, Singapore
Additional Information
Starting date: March 2006
Last updated: July 12, 2011
|