Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Laboi

ORCID ID

Contact details

Department of Renal Medicine
Wellcome Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 3757
comdhfo@stjames.leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118126

Study information

Scientific title

Acronym

Study hypothesis

To determine whether bacterial colonisation and subsequent bacteremia can be reduced using EDTA salt line- locks.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Haemodialysis

Intervention

Before-after trial; Laboratory study; Randomised controlled trial:
1. Standard vascular catheters for dialysis
2. Vascular catheter and EDTA line-lock

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Eradication of bacterial colonisation.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

03/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Haemodialysis patients dialysing with a central venous catheter on EPO therapy.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2003

Recruitment end date

03/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Renal Medicine
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes