Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters: a randomised controlled trial

ISRCTN	ISRCTN27307877
DOI	https://doi.org/10.1186/ISRCTN27307877
Secondary identifying numbers	N0158153706

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 M Abdalla
Scientific

Nephrology Department
North Staffordshire Royal Infirmary
Princes Road
Hartshill
Stoke-on-Trent
ST4 7LN
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title
Study objectives	To compare the effectiveness of 46.7% trisodium citrate versus unfractionated heparin (5000 IU/ml) in preventing clotting of tunnelled haemodialysis catheters.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Renal failure
Intervention	Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Trisodium citrate, unfractionated heparin
Primary outcome measure	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 study start date	01/02/2005
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2005
Date of final enrolment	01/08/2006

Nephrology Department

Stoke-on-Trent
ST4 7LN
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

North Staffordshire Research and Development Consortium (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan