A randomised controlled crossover trial of biofeedback control of end-dialysis plasma conductivity versus progressive reduction of dialysate conductivity.

ISRCTN	ISRCTN32121550
DOI	https://doi.org/10.1186/ISRCTN32121550
Secondary identifying numbers	N0077135300

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 21/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chris W McIntyre
Scientific

Derby Hospitals NHS Foundation Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Does Diacontrol improve haemodynamic stability in comparison with fixed dialysate sodium achieving identical end-dialysis plasma conductivity?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Renal
Intervention	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.
Intervention type	Other
Primary outcome measure	1. End-dialysis plasma conductivity 2. Numbers of patients achieving each reduction 3. Haemodynamic stability, assessed using a variety of measures
Secondary outcome measures	Not provided at time of registration
Overall study start date	18/12/2003
Completion date	18/05/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	32
Key inclusion criteria	Chronic haemodialysis patients
Key exclusion criteria	1. > 2 episodes of hypotension/week on current dialysis 2. On HDF
Date of first enrolment	18/12/2003
Date of final enrolment	18/05/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE22 3NE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007		Yes	No