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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital of North Staffordshire.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
St. James's Hospital, Ireland
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by:
University Hospital of North Staffordshire
ClinicalTrials.gov Identifier:
NCT00801112
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted

December 2, 2008
December 2, 2008
January 2009
Not Provided
Extra-cellular Fluid Volume (ECFv) determined from BIA to be maintained within pre-agreed limit of 1 liter. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Blood pressure control and residual urine volume. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood, urine and peritoneal fluid.

Non-Probability Sample

Incident and prevalent PD patients.

  • Fluid Status
  • Peritoneal Dialysis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
January 2011
Not Provided

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.
Both
16 Years and older
No
Contact: Simon J Davies, MD FRCP +44(0)1782 554164 simondavies1@compuserve.com
Contact: Kay B Tan, MB MRCP +44(0)1782 554185 tanbkay@doctors.org.uk
United Kingdom
 
NCT00801112
BIA-001MC
No
Professor Simon Davies, University Hospital of North Staffordshire
University Hospital of North Staffordshire
  • St. James's Hospital, Ireland
  • Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Simon J Davies, MD FRCP University Hospital of North Staffordshire
University Hospital of North Staffordshire
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP