Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182338
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2005-09-13
Brief Title:
Evaluation of Volume Status in Peritoneal Dialysis Patients
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Evaluation of Volume Status in Peritoneal Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population Recently two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease It is known that retaining too much fluid leads to high blood pressure and thickening of the heart wall Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and independence This study will measure blood levels of a protein called N-BNP and measure the extent of body fluid by a machine called a bioimpedance analyzer This device administers an undetectible electric current which distributes throughout total body water The relationship between these tests and the clinical presence of volume expansion will be assessed In addition the extent of total body fluid and its impact on heart attacks heart failure and stroke will be determined
Detailed Description:
Patients with end-stage renal disease ESRD have a higher risk than the general population of developing premature cardiovascular disease the reasons for this are complex Two recent randomized controlled trials in peritoneal dialysis patients have demonstrated that targeting patients to higher dialysis clearance values is not associated with a reduction in mortality It is known that patients on peritoneal dialysis are more likely to be volume expanded develop left ventricular hypertrophy and have inadequate blood pressure relative to patients on hemodialysis As a result there has been increased attention on the role of fluid management in reducing the risk of developing congestive heart failure and other adverse cardiovascular events in peritoneal dialysis patients
Extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis BIA Estimation of volume expansion by measuring the natriuretic peptide N-BNP produced by cardiac tissue in response to ventricular wall stretch can also be used
The purpose of this study is to determine whether volume status as measured by BIA and N-BNP levels correlates with clinical volume assessment cardiovascular outcomes peritoneal membrane transport properties and markers of inflammation such as serum albumin and C-reactive protein
Extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis BIA Estimation of volume expansion by measuring the natriuretic peptide N-BNP produced by cardiac tissue in response to ventricular wall stretch can also be used
The purpose of this study is to determine whether volume status as measured by BIA and N-BNP levels correlates with clinical volume assessment cardiovascular outcomes peritoneal membrane transport properties and markers of inflammation such as serum albumin and C-reactive protein
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None