Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Abdalla

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes