Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients
Recruitment status was Not yet recruiting
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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 |
|---|
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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 |
- 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 ]
- 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.
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2
PD patients with residual renal function <200ml with BIA monitor.
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3
PD patients with residual renal function >200ml without BIA monitor
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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 |
Incident and prevalent PD patients.
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| 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 | |
| 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 | |
| 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 May 19, 2013