NCT00312273

Brief Summary

The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
966

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
Last Updated

July 27, 2006

Status Verified

September 1, 2003

First QC Date

April 5, 2006

Last Update Submit

July 26, 2006

Conditions

Keywords

Heart ArrestCardiopulmonary ResuscitationAminophyllineBradycardiaHumansEmergency Medical Services

Outcome Measures

Primary Outcomes (1)

  • The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.

Secondary Outcomes (10)

  • Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)

  • ROSC duration by survival analysis

  • Survival to hospital admission

  • Survival to hospital discharge

  • Length of hospital stay

  • +5 more secondary outcomes

Interventions

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac arrest
  • Bradyasystole either as the presenting rhythm or as a rhythm developing during the course of the resuscitation
  • Endotracheally intubated and ventilated with 100% oxygen
  • Intravenous (IV) access established
  • Bradyasystolic without palpable pulses after 1 mg of epinephrine and 3 mg of atropine.

You may not qualify if:

  • A do-not-resuscitate directive
  • Pregnancy
  • Evidence of hemorrhage, trauma or hypothermia as a cause of the cardiac arrest
  • Renal dialysis
  • Theophylline hypersensitivity
  • Patients taking an oral theophylline product
  • Resuscitations directed by a paramedic student under practicum supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

  • Abu-Laban RB, McIntyre CM, Christenson JM, van Beek CA, Innes GD, O'Brien RK, Wanger KP, McKnight RD, Gin KG, Zed PJ, Watts J, Puskaric J, MacPhail IA, Berringer RG, Milner RA. Aminophylline in bradyasystolic cardiac arrest: a randomised placebo-controlled trial. Lancet. 2006 May 13;367(9522):1577-84. doi: 10.1016/S0140-6736(06)68694-7.

MeSH Terms

Conditions

Heart ArrestBradycardia

Interventions

Aminophylline

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsTheophyllineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Riyad B Abu Laban, MD, MHSc

    Department of Emergency Medicine, Vancouver General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

January 1, 2001

Study Completion

July 1, 2004

Last Updated

July 27, 2006

Record last verified: 2003-09

Locations