Bioimpedance as a tool for fluid management in peritoneal dialysis patients

ISRCTN	ISRCTN95439739
DOI	https://doi.org/10.1186/ISRCTN95439739
ClinicalTrials.gov number	NCT00801112
Secondary identifying numbers	N/A

Submission date: 29/11/2008
Registration date: 18/12/2009
Last edited: 11/01/2017

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

Prof Simon Davies
Scientific

Nephrology Department
University Hospital of North Staffordshire
Princes Road
Hartshill
Stoke on Trent
ST4 7LN
United Kingdom

Email	simondavies1@compuserve.com

Study information

Study design	Multi-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Developing bioimpedance as a tool for fluid management in peritoneal dialysis patients: a validation study
Study objectives	Regular monitoring of bioimpedance (BIA) adds value to the management of fluid status in peritoneal dialysis (PD) patients.
Ethics approval(s)	North Staffordshire Local Research Ethics Committee - submission pending as of 29/11/2008
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/01/2009
Completion date	15/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key inclusion criteria	1. All PD patients who are clinically stable 2. Age >16 years
Key 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
Date of first enrolment	15/01/2009
Date of final enrolment	15/11/2011

Locations

Countries of recruitment

England
Italy
Netherlands
Spain
Sweden
United Kingdom

Study participating centre

University Hospital of North Staffordshire

Stoke on Trent
ST4 7LN
United Kingdom

Sponsor information

University Hospital of North Staffordshire (UK)
Government

Princes Road
Hartshill
Stoke on Trent
ST4 7LN
United Kingdom

Email	darren.clement@uhns.nhs.uk
Website	http://www.uhns.nhs.uk

Funders

Funder type

Industry

Baxter (UK) - Clinical Evidence Council

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	01/02/2016		Yes	No

Editorial Notes

11/01/2017: Publication reference added.