Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000493246
Ethics application status
Approved
Date submitted
9/06/2009
Date registered
22/06/2009
Date last updated
17/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ethanol lock therapy for the prevention of tunnelled intravenous catheter-associated bacteraemias in patients with chronic renal failure undergoing haemodialysis via a central venous catheter insitu
Scientific title
Ethanol lock therapy for the prevention of tunnelled intravenous catheter-associated bacteraemias in patients with chronic renal failure undergoing haemodialysis via a central venous catheter insitu
Secondary ID [1] 893 0
CRG090700120 (Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
Ethanol Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection related to central lines 236954 0
Condition category
Condition code
Infection 237304 237304 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 mL intravenous 70% ethanol is instilled into each lumen of the tunnelled intravenous catheter as a lock, at the end of the haemodialysis treatment, once weekly. The ethanol is withdrawn before the next dialysis session, 48 hours later. The patient remains on the study until the catheter is removed.
Intervention code [1] 236731 0
Treatment: Drugs
Comparator / control treatment
Three times weekly, as per usual practice, Heparin (5000 units per mL) is instilled into each lumen of the tunnelled intravenous catheter as a lock (volume as per lumen instructions - this amount is variable depending on the brand of catheter/size of lumen), at the end of the haemodialysis treatment and withdrawn before the next dialysis session, 48 hours later. The patient remains on the study until the catheter is removed.
Control group
Active

Outcomes
Primary outcome [1] 238113 0
Time to catheter removal, due to sepsis, bacteraemia or if it is no longer needed.
Timepoint [1] 238113 0
Following randomisation and weekly Ethanol treatment, the time to catheter removal is monitored continuously.
Secondary outcome [1] 242326 0
Time to the first episode of catheter-related bacteraemia. This is assessed by medical examination and blood culture results.
Timepoint [1] 242326 0
Following randomisation and weekly Ethanol / Heparin treatment, time to the first episode of catheter-related bacteraemia is monitored continuously until the catheter is removed.
Secondary outcome [2] 242447 0
Incidence of catheter-related bacteraemia caused by different pathogens.
Timepoint [2] 242447 0
Blood cultures will be taken if clinically indicated as assessed by medical staff.
Secondary outcome [3] 242463 0
Time to infection-related catheter removal
Timepoint [3] 242463 0
Assessed by medical examination and blood culture results, necessitating catheter removal.
Secondary outcome [4] 242464 0
Adverse reactions such as problems with dialysis flow, lumen and dialysis clotting.
Timepoint [4] 242464 0
Assessed by medical and nursing staff at each dialysis session by examination. A trial safety committee is set up to allow external evaluation of catheter-related problems at 6 months and annually after that period.
Secondary outcome [5] 242465 0
Time to exit site infection
Timepoint [5] 242465 0
Assessed by medical and nursing staff at each dialysis session and microbiological results of exit site wound swabs.
Secondary outcome [6] 242471 0
Quality of life
Timepoint [6] 242471 0
Patients will be assessed for Quality of Life, using the EQ-5D questionnaire, on a monthly basis.
Secondary outcome [7] 242474 0
Economic cost
Timepoint [7] 242474 0
Hospital-associated costs (length of stay of hospital admissions, pharmacy costs, laboratory/radiology costs) plus other healthcare service costs (General Practitioner (GP) visits)

Eligibility
Key inclusion criteria
Tunnelled central venous catheter in situ.
Undergoing haemodialysis for chronic renal failure via the catheter.
Agree to inclusion in the study.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of current central venous catheter infection.
Pregnant or breast feeding females.
Religious objection to ethanol lock therapy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are identified, recruited, consented and randomised by study staff. Stratification will occur for Incident versus Prevelent catheters. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment is assured using a centralised computer-generated block randomisation procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Outcome assessment based on standardised and objective criteria will be performed blinded to treatment allocation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1790 0
4102

Funding & Sponsors
Funding source category [1] 237129 0
Charities/Societies/Foundations
Name [1] 237129 0
Princess Alexandra Hospital Foundation
Country [1] 237129 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Princess Alexandra Hospital Foundation
Address
199 Ipswich Road
Woolloongabba
Brisbane Queensland 4102
Country
Australia
Secondary sponsor category [1] 4620 0
None
Name [1] 4620 0
Address [1] 4620 0
Country [1] 4620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239226 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 239226 0
199 Ipswich Road
Wolloongabba
Brisbane Queensland 4102
Ethics committee country [1] 239226 0
Australia
Date submitted for ethics approval [1] 239226 0
16/03/2007
Approval date [1] 239226 0
31/08/2007
Ethics approval number [1] 239226 0
2007/049

Summary
Brief summary
The study is to lock a small amount of Ethanol in the center of the line for 48 hours each week in patients who have a tunnelled line, to prevent the development of catheter-associated bacteraemia in haemodialysis patients.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 29719 0
Address 29719 0
Country 29719 0
Phone 29719 0
Fax 29719 0
Email 29719 0
Contact person for public queries
Name 12966 0
Dr Jennifer Broom
Address 12966 0
Department of Medicine
Nambour General Hospital
1 Hospital Road
Nambour Queensland 4560
Country 12966 0
Australia
Phone 12966 0
61 7 547 60568
Fax 12966 0
Email 12966 0
jennifer_broom@health.qld.gov.au
Contact person for scientific queries
Name 3894 0
Dr Jennifer Broom
Address 3894 0
Department of Medicine
Nambour General Hospital
1 Hospital Road
Nambour Queensland 4560
Country 3894 0
Australia
Phone 3894 0
61 7 547 60568
Fax 3894 0
Email 3894 0
jennifer_broom@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.