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
  Purpose

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.


Condition
Fluid Status
Peritoneal Dialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Bioimpedance (BIA) as a Tool for Fluid Management in Peritoneal Dialysis Patients: A Validation Study

Resource links provided by NLM:


Further study details as provided by University Hospital of North Staffordshire:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Blood pressure control and residual urine volume. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood, urine and peritoneal fluid.


Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Incident and prevalent PD patients.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801112

Contacts
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

Locations
United Kingdom
University Hospital of North Staffordshire Not yet recruiting
Stoke on Trent, Staffordshire, United Kingdom, ST4 7LN
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   
Sponsors and Collaborators
University Hospital of North Staffordshire
St. James's Hospital, Ireland
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Simon J Davies, MD FRCP University Hospital of North Staffordshire
  More Information

No publications provided

Responsible Party: Professor Simon Davies, University Hospital of North Staffordshire
ClinicalTrials.gov Identifier: NCT00801112     History of Changes
Other Study ID Numbers: BIA-001MC
Study First Received: December 2, 2008
Last Updated: December 2, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital of North Staffordshire:
Bioimpedance
Fluid status
Peritoneal Dialysis
Extra-cellular fluid volume

ClinicalTrials.gov processed this record on July 20, 2014