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

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

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.

Study Overview

• Status: Unknown
• Conditions: Peritoneal Dialysis; Fluid Status

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Simon J Davies, MD FRCP; Phone Number: +44(0)1782 554164; Email: simondavies1@compuserve.com
• Study Contact Backup: Name: Kay B Tan, MB MRCP; Phone Number: +44(0)1782 554185; Email: tanbkay@doctors.org.uk

Study Locations

• United Kingdom
  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST4 7LN
      • University Hospital of North Staffordshire
      • Contact: Simon J Davies, MD FRCP; Phone Number: +44(0)1782 554164; Email: simondavies1@compuserve.com
      • Contact: Kay B Tan, MB MRCP; Phone Number: +44(0)1782 554185; Email: tanbkay@doctors.org.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Incident and prevalent PD patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
1; PD patients with residual renal function >200ml with BIA monitor.
2; PD patients with residual renal function <200ml with BIA monitor.
3; PD patients with residual renal function >200ml without BIA monitor
4; PD patients with residual renal function <200ml without BIA monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Extra-cellular Fluid Volume (ECFv) determined from BIA to be maintained within pre-agreed limit of 1 liter.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure control and residual urine volume.	12 months

Collaborators and Investigators

• Sponsor: University Hospital of North Staffordshire
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust; St. James's Hospital, Ireland
• Investigators: Principal Investigator: Simon J Davies, MD FRCP, University Hospital of North Staffordshire

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2008
• Last Update Submitted That Met QC Criteria: December 2, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; Bioimpedance; Fluid status; Extra-cellular fluid volume
• Other Study ID Numbers: BIA-001MC