Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000938909
Ethics application status
Approved
Date submitted
31/08/2011
Date registered
31/08/2011
Date last updated
15/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Saline Therapy for Reducing Alcohol Intoxication
Scientific title
Effect of Intravenous 0.9% Saline Therapy Compared to Observation Alone on Emergency Department Length of Stay and Symptomatology in Adult Patients Presenting to an Emergency Department with Uncomplicated Acute Alcoholic Intoxication
Secondary ID [1] 262967 0
Nil
Universal Trial Number (UTN)
U1111-1124-1966
Trial acronym
STRAIn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute alcohol intoxication 270692 0
Condition category
Condition code
Mental Health 270867 270867 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of intravenous 0.9% Saline given as a bolus of 20ml/kg bodyweight
Intervention code [1] 269308 0
Treatment: Drugs
Comparator / control treatment
Observation only
Control group
Active

Outcomes
Primary outcome [1] 279547 0
Emergency department length of stay
Timepoint [1] 279547 0
Triage time to actual discharge time
Secondary outcome [1] 287877 0
Sign of alcohol intoxication as measured by the Observed Assessment of Alcohol Intoxication tool
Timepoint [1] 287877 0
Measurement with the OAAI tool will be conducted on arrival of the participants to the emergency department and again prior to discharge
Secondary outcome [2] 287879 0
Associated costs of resource utilization for both groups of patients (control and treatment) based on healthcare personnel, materials and time consumed
Timepoint [2] 287879 0
duration of participants stay in the emergency department

Eligibility
Key inclusion criteria
Participants will be enrolled into the study by an independent nurse, research assistant or doctor who will determine if they are adults between the age of 18-50 years, presenting with an acceptable uncomplicated history of acute alcohol intoxication (no injuries, no overdose, no psychiatric conditions requiring ongoing investigation or treatment), with an otherwise unremarkable physical examination.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Children and young people less than 18 years of age, people with intellectual or mental impairment, women who may be pregnant and the human fetus are excluded from this study. Patients who refuse breath alcohol level analyser, IV cannula insertion, and bloods testing will be excluded as well. Patients who are found to have significant injuries (i.e head injury) or concomitant conditions (overdose) requiring further investigation or treatment will also be excluded. Patients requiring airway support more than a nasopharyngeal airway or Gudell airway (i.e. endotrachael or nasotrachael intubation) will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Waiver of consent has been obtained for this research. Every patient that is eligible based on inclusion and exclusion criteria will be enrolled. Randomisation is done by an independent statistician.

Within the blocked design, odd numbers are allocated to the control group and even numbers are allocated to the treatment group. The allocation to either control or treatment group is printed on a 4x6cm paper, folded in half three times, then placed in individual sequentially-numbered opaque sealed envelopes (SNOSE). These envelopes are to be opened only after a patient is ready for allocation to either control or treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will generate the number sequence using computerized sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
No placebo is used because the control group is for observation only.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4434 0
4215
Recruitment postcode(s) [2] 4435 0
4226

Funding & Sponsors
Funding source category [1] 269774 0
Charities/Societies/Foundations
Name [1] 269774 0
Queensland Emergency Medicine Research Foundation
Country [1] 269774 0
Australia
Primary sponsor type
Individual
Name
Dr Siegfried Perez
Address
Gold Coast Hospital
Department of Emergency Medicine
108 Nerang Street, Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 268814 0
Individual
Name [1] 268814 0
Dr Gerben Keijzers
Address [1] 268814 0
Gold Coast Hospital
Department of Emergency Medicine
108 Nerang Street, Southport, QLD 4215
Country [1] 268814 0
Australia
Other collaborator category [1] 252242 0
Hospital
Name [1] 252242 0
Gold Coast Hospital - Department of Emergency Medicine
Address [1] 252242 0
108 Nerang Street
Southport, QLD 4215
Country [1] 252242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271732 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [1] 271732 0
GCHSD HREC
Queensland Health
10 Little High Street
Southport, 4215
Ethics committee country [1] 271732 0
Australia
Date submitted for ethics approval [1] 271732 0
25/08/2010
Approval date [1] 271732 0
10/01/2011
Ethics approval number [1] 271732 0
HREC/10/QGC/113

Summary
Brief summary
Our study aims to fill a knowledge gap about a highly relevant question for emergency medicine that has not had any solid research behind it. We aim to prove or disprove if there is any evidence in giving intravenous 0.9 NaCl to the length of stay and symptoms of patients presenting to the emergency department with alcohol intoxication. We will also consider the economic costs of providing intravenous saline and associated ED stay for these patients compared to observation alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33099 0
Address 33099 0
Country 33099 0
Phone 33099 0
Fax 33099 0
Email 33099 0
Contact person for public queries
Name 16346 0
Dr Siegfried Perez
Address 16346 0
Gold Coast Hospital
Department of Emergency Medicine
108 Nerang Street, Southport, QLD 4215
Country 16346 0
Australia
Phone 16346 0
+617 55198211
Fax 16346 0
Email 16346 0
siegfried_robert_perez@health.qld.gov.au
Contact person for scientific queries
Name 7274 0
Siegfried Perez
Address 7274 0
Gold Coast Hospital
Department of Emergency Medicine
108 Nerang Street, Southport, QLD 4215
Country 7274 0
Australia
Phone 7274 0
+617 55198211
Fax 7274 0
Email 7274 0
Siegfried_Robert_Perez@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.