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ISRCTN
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ISRCTN95439739
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ClinicalTrials.gov identifier
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Public title
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Bioimpedance as a tool for fluid management in peritoneal dialysis (PD) patients
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Scientific title
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Developing bioimpedance (BIA) as a tool for fluid management in peritoneal dialysis (PD) patients: a validation study
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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We hypothesise that regular monitoring of bioimpedance (BIA) adds value to the management of fluid status in peritoneal dialysis (PD) patients.
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Lay summary
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Ethics approval
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To be submitted to the North Staffordshire Local Research Ethics Committee as of 29/11/2008.
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Study design
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Multi-centre randomised controlled trial
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Countries of recruitment
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Italy, Netherlands, Spain, Sweden, United Kingdom
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Disease/condition/study domain
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End stage renal disease on peritoneal dialysis
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Participants - inclusion criteria
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1. All PD patients who are clinically stable
2. Age >16 years
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Participants - exclusion criteria
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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
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Anticipated start date
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15/01/2009
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Anticipated end date
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15/11/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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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.
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Primary outcome measure(s)
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Extra-cellular fluid volume (ECFv) determined from BIA.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Baxter (UK) -Clinical Evidence Council
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Trial website
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Publications
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Contact name
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Prof
Simon
Davies
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Address
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Nephrology Department
University Hospital of North Staffordshire
Princes Road
Hartshill
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City/town
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Stoke on Trent
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Zip/Postcode
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ST4 7LN
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Country
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United Kingdom
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Email
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simondavies1@compuserve.com
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Sponsor
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University Hospital of North Staffordshire (UK)
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Address
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Princes Road
Hartshill
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City/town
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Stoke on Trent
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Zip/Postcode
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ST4 7LN
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Country
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United Kingdom
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Email
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darren.clement@uhns.nhs.uk
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Sponsor website:
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http://www.uhns.nhs.uk
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Date applied
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29/11/2008
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Last edited
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18/12/2009
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Date ISRCTN assigned
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18/12/2009
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