Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/04/2011
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 Chris W McIntyre

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077135300

Study information

Scientific title

Acronym

Study hypothesis

Does Diacontrol improve haemodynamic stability in comparison with fixed dialysate sodium achieving identical end-dialysis plasma conductivity?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

18/12/2003

Overall trial end date

18/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Chronic haemodialysis patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

32

Participant exclusion criteria

1. > 2 episodes of hypotension/week on current dialysis
2. On HDF

Recruitment start date

18/12/2003

Recruitment end date

18/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
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

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

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17413560

Publication citations

  1. Results

    Selby NM, Taal MW, McIntyre CW, Comparison of progressive conductivity reduction with diacontrol and standard dialysis., ASAIO J., 53, 2, 194-200, doi: 10.1097/01.mat.0000250787.65643.b8.

Additional files

Editorial Notes