Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest

NCT00358579 | Completed Phase 3 Results DMC

• 1 other identifier: SQCA01
• Study Type: interventional
• Target: 727
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiac Arrest

Keywords

Vasopressin; Adrenaline; Survival; Return of spontaneous of circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.

  at 30 days post arrest

• Neurological Status at 1 Year.

  at 1 year post arrest

• Return of Spontaneous Circulation.

  during resuscitation

• Survival to Admission.

  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

Study Arms (2)

Adrenaline

ACTIVE COMPARATOR

Drug: Adrenaline

Vasopressin

ACTIVE COMPARATOR

Drug: Vasopressin

Interventions

Adrenaline DRUG

1 mg

Also known as: Epinephrine

Adrenaline

Vasopressin DRUG

40 IU

Also known as: Arginine vasopressin, argipressin, antidiuretic hormone

Vasopressin

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Traumatic cardiac arrest
• Age 16 and below (Age 20 and below for CGH only)
• CPR is contraindicated

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Alexandra Hospital: collaborator
• National University Hospital, Singapore: collaborator
• Changi General Hospital: collaborator

Study Sites (4)

National University Hospital

Singapore, 119074, Singapore

Location

Alexandra Hospital

Singapore, 159964, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• 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.

  PMID: 22353644 DERIVED

MeSH Terms

Conditions

Heart Arrest; Diabetes Insipidus

Interventions

Epinephrine; Vasopressins; Arginine Vasopressin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

As the study was conducted over a relatively long period, results may be affected by secular trends.Variations in post-resuscitation care can affect survival to discharge status and variations between institutions are difficult to account for.

Results Point of Contact

• Title: A/Prof Marcus Ong Eng Hock
• Organization: Singapore General Hospital

marcus.ong.e.h@sgh.com.sg

+6563213590

Study Officials

• Marcus EH Ong, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2006
• First Posted: August 1, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 17, 2017
• Results First Posted: August 9, 2011

Record last verified: 2017-02

Locations

SG (4)