Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/04/2015
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

N0077114320

Study information

Scientific title

Study into achievement of isonatric haemodialysis by individual tailoring of dialysate sodium according to ionic mass balance derived from online conductance monitoring

Acronym

Study hypothesis

Whether or not individualising dialysate sodium has beneficial effects on haemodialysis patients interdialytic weight gains, blood pressure and thirst when compared to standard dialysate sodium.

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

Treatment

Patient information sheet

Condition

Urological and Genital Diseases: Renal dialysis

Intervention

The two groups will both undergo a 1-week period of initial data collection while being maintained on routine dialysis. Dialysis will be performed using a default dialysate sodium of 140 mmol/l.
The first group will then continue to dialyse against a standard dialysate sodium concentration of 140 mmol/l, while the second group undergoes a period of 1 month of sequential reduction of dialysate sodium according to online conductivity monitoring, aiming for isonatric dialysis (i.e. Ionic mass balance of 0-100 mmol of sodium). This will then be maintained for a period of one month.
After that time, there will be a crossover period of adjustment, during which the first group will have their dialysate sodium tailored to their requirements, and the second group will revert in a gradual manner to a dialysate sodium of 140 mmol/l.
Again the two groups will be maintained for a further month, before both groups revert to a standard dialysate sodium at the end of the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Neutral sodium balance as assessed by ionic mass balance reduction in interdialytic weight gain.

Secondary outcome measures

Pre and post dialysis blood pressure, number of anti-hypertensive agents stability on dialysis, thirst score.

Overall trial start date

23/09/2002

Overall trial end date

23/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients on routine haemodialysis

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

We plan to enrol 60 - 100 patients currently established on haemodialysis.

Participant exclusion criteria

No documented exclusion criteria. Protocol specifies ALL patients on established haemodialysis.

Recruitment start date

23/09/2002

Recruitment end date

23/03/2004

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

Publication citations

Additional files

Editorial Notes