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

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)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Drug: Adrenaline; Drug: Vasopressin

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).

• Study Type: Interventional
• Enrollment (Actual): 727
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 159964
    • Alexandra Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adrenaline	Drug: Adrenaline; 1 mg; Other Names: Epinephrine
Active Comparator: Vasopressin	Drug: Vasopressin; 40 IU; Other Names: Arginine vasopressin; argipressin; antidiuretic hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 30 days post arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 30 days post arrest
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.	at 1 year post arrest
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.	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.	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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: National University Hospital, Singapore; Changi General Hospital; National Medical Research Council (NMRC), Singapore; Alexandra Hospital
• Investigators: Principal Investigator: Marcus EH Ong, MBBS, Singapore General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: July 30, 2006
• First Submitted That Met QC Criteria: July 30, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Survival; Adrenaline; Vasopressin; Return of spontaneous of circulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Hemostatics; Coagulants; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Antidiuretic Agents; Epinephrine; Racepinephrine; Epinephryl borate; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: SQCA01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No