Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest - Full Text View

Sponsors and Collaborators:	Singapore General Hospital National Medical Research Council (NMRC), Singapore Alexandra Hospital, Singapore National University Hospital, Singapore Changi General Hospital
Information provided by:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT00358579

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. Over the years, research on intravenous adrenaline have not shown adrenaline to improve survival rate.

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: Vasopressin Drug: Adrenaline	Phase III

Drug Information available for: Epinephrine Epinephrine bitartrate Argipressin Vasopressins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:

Survival to hospital discharge [ Time Frame: at 30 days post arrest ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurological status on discharge or at 30 days post arrest, if not discharged [ Time Frame: at 30 days post arrest ] [ Designated as safety issue: No ]
Neurological status at 1 year [ Time Frame: at 1 year post arrest ] [ Designated as safety issue: No ]
Return of spontaneous circulation [ Time Frame: during resuscitation ] [ Designated as safety issue: No ]
Survival to admission [ Time Frame: during resuscitation ] [ Designated as safety issue: No ]

Estimated Enrollment:	720
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Vasopressin vasopressin 40U
2: Active Comparator	Drug: Adrenaline adrenaline 1mg

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. Over the years, research on intravenous adrenaline have not shown adrenaline to improve survival rate.

More recently vasopressin has been used in patients with cardiac arrest. Through animal models, it has been shown that vasopressin is more effective than adrenaline in ventricular fibrillation. In human studies, the results have been conflicting.

The International Liaison Committee on Resuscitation (ILOR) 2000 guidelines currently recommends both adrenaline and vasopressin as equal alternatives for cardiac arrest, pending further evidence. Similarly, the National Resuscitation Council of Singapore has adopted similar guidelines. However, the question still remains, which is the more effective drug, adrenaline or vasopressin?

The objective of the study is to compare vasopressin and adrenaline in the treatment of cardiac arrest with respect to:

Return of spontaneous circulation
Survival to admission
Survival to discharge
Neurological status on discharge or at 30 days post arrest, if not discharged
Neurological status at 1 year

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358579

Contacts

Contact: Marcus EH Ong, MD

+65-63213590

Locations

Singapore
Singapore General Hospital	Recruiting
Singapore, Singapore, 169608
Principal Investigator: Marcus EH Ong, MD
Alexandra Hospital	Terminated
Singapore, Singapore, 159964
National University Hospital	Recruiting
Singapore, Singapore, 119074
Principal Investigator: Benjamin SH Leong, MD
Changi General Hospital	Recruiting
Singapore, Singapore, 529889
Principal Investigator: Ling Tiah, MD

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, MD

Singapore General Hospital

More Information

Responsible Party:	Singapore General Hospital ( Marcus Ong EH )
Study ID Numbers:	SQCA01
Study First Received:	July 30, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00358579
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:

Vasopressin
Adrenaline
Survival
Return of spontaneous of circulation

Study placed in the following topic categories:

Arginine Vasopressin
Heart Diseases
Vasopressins

Emergencies
Heart Arrest
Epinephrine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Coagulants
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Hematologic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents

Hemostatics
Pharmacologic Actions
Adrenergic Agonists
Mydriatics
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Peripheral Nervous System Agents
Antidiuretic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009