Prevention of microbial colonisation using ethylene diamine tetraacetic acid (EDTA) line locks and its effect on erythropoietin (EPO) resistance in haemodialysis patients using temporary vascular catheters - a prospective study

ISRCTN	ISRCTN72100010
DOI	https://doi.org/10.1186/ISRCTN72100010
Protocol serial number	N0436118126
Sponsor	Department of Health (UK)
Funder	Leeds Teaching Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr P Laboi
Scientific

Department of Renal Medicine
Wellcome Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 3757
Email	comdhfo@stjames.leeds.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine whether bacterial colonisation and subsequent bacteremia can be reduced using EDTA salt line- locks.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Eradication of bacterial colonisation.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	03/04/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Haemodialysis patients dialysing with a central venous catheter on EPO therapy.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2003
Date of final enrolment	03/04/2005

Department of Renal Medicine

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan