Condition category
Urological and Genital Diseases
Date applied
29/11/2008
Date assigned
18/12/2009
Last edited
04/08/2014
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

Prof Simon Davies

ORCID ID

Contact details

Nephrology Department
University Hospital of North Staffordshire
Princes Road
Hartshill
Stoke on Trent
ST4 7LN
United Kingdom
simondavies1@compuserve.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Developing bioimpedance (BIA) as a tool for fluid management in peritoneal dialysis (PD) patients: a validation study

Acronym

Study hypothesis

We hypothesise that regular monitoring of bioimpedance (BIA) adds value to the management of fluid status in peritoneal dialysis (PD) patients.

Ethics approval

North Staffordshire Local Research Ethics Committee – submission pending as of 29/11/2008

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

End stage renal disease on peritoneal dialysis

Intervention

Clinician to use whatever tools at their disposal to achieve dry weight in PD patients including restricted dietary salt and fluid intake, increased use of hypertonic PD solutions and modality change. BIA to track fluid status changes. BIA measurements will also be taken for the control group but the results will not be acted upon

BIA measurements for all patients will be taken at 3 months intervals. The total duration of the intervention is 1 year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Extra-cellular fluid volume (ECFv) determined from BIA.

Secondary outcome measures

Outcomes will be measured at 6-month intervals
1. Blood pressure control (clinic)
2. Residual urine volume:
2.1. Development of anuria (<200 ml/day)
2.2. Time to halving of urine volume at randomisation
3. Membrane function:
3.1. Glucose exposure
3.2. Solute transport
3.3. Ultrafiltration (UF) capacity
3.4. Free water transport (limited centres, own resources)
4. Cardiac function:
4.1. Brain natriuretic peptide (BNP) (all centres)
4.2. Echocardiography (ECHO) (limited centres, own resources)
5. Fluid status using gold standard methods (limited centres, own resources)

Overall trial start date

15/01/2009

Overall trial end date

15/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. All PD patients who are clinically stable
2. Age >16 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients planning discontinuation of PD within 6 months
2. Patients who are unable to give consent
3. Patients who have peritonitis the last 30 days prior to study enrollment
4. Patients who are pregnant

Recruitment start date

15/01/2009

Recruitment end date

15/11/2011

Locations

Countries of recruitment

Italy, Netherlands, Spain, Sweden, United Kingdom

Trial participating centre

Nephrology Department
Stoke on Trent
ST4 7LN
United Kingdom

Sponsor information

Organisation

University Hospital of North Staffordshire (UK)

Sponsor details

Princes Road
Hartshill
Stoke on Trent
ST4 7LN
United Kingdom
darren.clement@uhns.nhs.uk

Sponsor type

Government

Website

http://www.uhns.nhs.uk

Funders

Funder type

Industry

Funder name

Baxter (UK) - Clinical Evidence Council

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