Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0158153706
Study information
Scientific title
Acronym
Study hypothesis
To compare the effectiveness of 46.7% trisodium citrate versus unfractionated heparin (5000 IU/ml) in preventing clotting of tunnelled haemodialysis catheters.
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
Renal failure
Intervention
Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters.
Intervention type
Drug
Phase
Not Applicable
Drug names
Trisodium citrate, unfractionated heparin
Primary outcome measures
Catheter blood flow of less than 250 ml/minute and/or venous pressure of more than 260 mmHg, persisting for one hour/session, in two consecutive sessions.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2005
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient who require a new tunnelled catheter for haemodialysis. Patients fall into three groups:
1. Patients who present to the kidney unit of the UHNS with kidney failure needing maintenance haemodialysis
2. Patients who have to switch from peritoneal to haemodialysis because of problems with their peritoneal dialysis
3. Existing haemodialysis patients who need tunnelled catheters because their arterivenous fistulas or tunnelled catheters have failed
The decision to place a tunnelled dialysis catheter is made by one of the renal consultants entirely on the basis of clinical need. Patients will be invited to take part prior to insertion of the tunnelled dialysis catheter. Randomisation will be by sealed envelopes. The only differences in dialysis care that patients will have is the locking agent, otherwise patients will have the same treatment whether they are dialysing in our main renal unit in Stoke or our two satellite units at Stafford and Leighton. They will be followed up and all dialysis-related issues will be documented as per current practice.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2005
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nephrology Department
Stoke-on-Trent
ST4 7LN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Staffordshire Research and Development Consortium (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