Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients
Recruitment status was Not yet recruiting
|First Received Date ICMJE||December 2, 2008|
|Last Updated Date||December 2, 2008|
|Start Date ICMJE||January 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Blood pressure control and residual urine volume. [ Time Frame: 12 months ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients|
|Official Title ICMJE||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.
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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
Whole blood, urine and peritoneal fluid.
|Sampling Method||Non-Probability Sample|
Incident and prevalent PD patients.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||100|
|Estimated Completion Date||January 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||16 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT00801112|
|Other Study ID Numbers ICMJE||BIA-001MC|
|Has Data Monitoring Committee||No|
|Responsible Party||Professor Simon Davies, University Hospital of North Staffordshire|
|Study Sponsor ICMJE||University Hospital of North Staffordshire|
|Information Provided By||University Hospital of North Staffordshire|
|Verification Date||December 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP