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ISRCTN
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ISRCTN32121550
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled crossover trial of biofeedback control of end-dialysis plasma conductivity versus progressive reduction of dialysate conductivity.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0077135300
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Study hypothesis
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Does Diacontrol improve haemodynamic stability in comparison with fixed dialysate sodium achieving identical end-dialysis plasma conductivity?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and Genital Diseases: Renal
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Participants - inclusion criteria
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Chronic haemodialysis patients
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Participants - exclusion criteria
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1. > 2 episodes of hypotension/week on current dialysis
2. On HDF
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Anticipated start date
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18/12/2003
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Anticipated end date
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18/05/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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32
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Interventions
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We propose to randomise patients to serial reduction of fixed dialysate conductivity or to reduction of end-dialysis plasma conductivity achieved using a biofeedback loop (Diacontrol). Diacontrol monitors plasma conductivity and adjusts dialysate conductivity to achieve a prescribed end-dialysis plasma conductivity. This should deliver a specific end-dialysis total body sodium, thus automatically adjusting for variation in interdialytic kietary sodium intake. Haemodynamic stability on dialysis should be improved with this technique, allowing more patients to reap the benefits of low dialysate conductivity.
Two groups of patients will have either Diacontrol or fixed dialysate conductivity. After serial reduction, the groups will cross over to the other modality. At the end of the trial all patients will revert to the unit standard dialysate of 13.6 mS/cm.
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Primary outcome measure(s)
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1. End-dialysis plasma conductivity
2. Numbers of patients achieving each reduction
3. Haemodynamic stability, assessed using a variety of measures
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17413560
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Contact name
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Dr
Chris W
McIntyre
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Address
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Derby Hospitals NHS Foundation Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
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City/town
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Derby
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Zip/Postcode
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DE22 3NE
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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21/04/2011
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Date ISRCTN assigned
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30/09/2005
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