Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients

Peritoneal Dialysis Clinical Trial

Official title:

Developing Bioimpedance (BIA) as a Tool for Fluid Management in Peritoneal Dialysis Patients: A Validation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00801112
• Other study ID #: BIA-001MC
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2008
• Last updated: December 2, 2008
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2008
• Source: University Hospital of North Staffordshire
• Contact: Simon J Davies, MD FRCP
• Phone: +44(0)1782 554164
• Email: simondavies1[@]compuserve.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the management of fluid status in PD patients

Objectives of the study: The objective is to show that in patients where the additional information of body composition is available to the clinician that the ECFv is maintained within pre-agreed limits, ~ 1 liter, over the observation period of 12 months.

SCIENTIFIC BACKGROUND:

Low peritoneal ultrafiltration, and by inference low sodium removal, is associated with worse outcomes in PD. Equally, excessive fluid removal is a risk factor for dehydration and loss of residual renal function. Current guidelines have advocated a daily UF volume of 1litre; their blunt application could lead to either inappropriate early loss of residual function or modality transfer. There is a significant need for evidence on how to best manage fluid status in PD patients, both in terms of an appropriate clinical strategy and also a simple but reproducible tool to guide clinicians in how to apply this strategy.

It is likely that BIA will become the standard tool to aid clinicians in assessing fluid status. It is simple to perform, intervention studies have demonstrated its ability to identify changes in fluid status in response to changes in therapy and it is a powerful predictor of patient survival. There is, however a clear need at this stage for proof of principle studies to establish its true potential for added value in the routine management of patients.

Body composition changes spontaneously with time on PD. Short term changes in hydration (specifically extracellular fluid volume, ECFv) combined with medium term changes in muscle and fat make it difficult for the clinician to be sure if fluid status is stable. It is anticipated that regular BIA measurements will aid the clinician in managing this problem over and above monitoring of weight and fluid status. By randomizing patients into two groups who have regular BIA measurements, one of which the BIA data is available to the clinician it will be possible to see if these spontaneous changes in body composition can be accounted for.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All PD patients who are clinically stable

Exclusion Criteria:

• Patients planning discontinuation of PD within 6 months.

• Patients who are unable to give consent.

• Patients who have peritonitis the last 30 days prior to study enrollment.

• Patients who are pregnant.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fluid Status
• Peritoneal Dialysis

Locations

Country	Name	City	State
United Kingdom	University Hospital of North Staffordshire	Stoke on Trent	Staffordshire

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Staffordshire	Sheffield Teaching Hospitals NHS Foundation Trust, St. James's Hospital, Ireland

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extra-cellular Fluid Volume (ECFv) determined from BIA to be maintained within pre-agreed limit of 1 liter.		12 months	No
Secondary	Blood pressure control and residual urine volume.		12 months	No