Clinical trial NCT00358579: Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Arrest
Keywords: Vasopressin
Adrenaline
Survival
Return of spontaneous of circulation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: Alexandra Hospital
name: National University Hospital, Singapore
name: Changi General Hospital
First posted: 2006-08-01
Enrollment: 727
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Survival to Hospital Discharge.
timeFrame: at 30 days post arrest
Secondary outcomes:
measure: Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.
timeFrame: at 30 days post arrest
measure: Neurological Status at 1 Year.
timeFrame: at 1 year post arrest
measure: Return of Spontaneous Circulation.
timeFrame: during resuscitation
measure: Survival to Admission.
timeFrame: 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
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Alexandra Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Marcus EH Ong, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.