Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440908
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2007-02-26
Brief Title:
Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers
Sponsor:
Fresenius Medical Care North America
Organization:
Fresenius Medical Care North America
Study Overview
Official Title:
A Prospective Observational Cohort Study Tracking Laboratory Markers for Changes Over Time After Converting Dialyzer Practice From Reuse to Single Use in Outpatient Dialysis Units
Status:
COMPLETED
Status Verified Date:
2008-05
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:
The study is a prospective cohort trial utilizing sequential laboratory results from excess serum obtained from hemodialysis patients acting as their own controls The objective of this study is to determine the impact of converting from reuse to single use of dialyzers on specific markers of nutrition pre-albumin and inflammation CRP in hemodialysis patients followed over a period of 6-months after conversion The Hypothesis is Comparing values obtained at baseline to values at the end of 6-months after conversion from reuse to single use in the same patients
1 In patients with baseline CRP 5 mgL Mean decrease of 5 mgL
2 In patients with baseline CRP 5 mgL 95 will remain 5 mgL
3 Mean serum pre-albumin levels will increase by at least 3 mgdL The study population will be drawn from 2900 patients that are currently undergoing hemodialysis in 48 dialysis units that have been identified as continuing to reuse dialyzers and specifically are using a peracetic acid-based disinfectant Renalin as of February 1 2007 These facilities will be scheduled to convert to single use of dialyzers between May and December 2007 The selection of patients will depend solely on the facility conversion date on a first-come first-served basis All patients within the dialysis facility that provide blood specimen for their routine monthly lab draws will be eligible The facilities and patients will be enrolled consecutively until the desired sample size of approximately 2500 patients is reached
1 In patients with baseline CRP 5 mgL Mean decrease of 5 mgL
2 In patients with baseline CRP 5 mgL 95 will remain 5 mgL
3 Mean serum pre-albumin levels will increase by at least 3 mgdL The study population will be drawn from 2900 patients that are currently undergoing hemodialysis in 48 dialysis units that have been identified as continuing to reuse dialyzers and specifically are using a peracetic acid-based disinfectant Renalin as of February 1 2007 These facilities will be scheduled to convert to single use of dialyzers between May and December 2007 The selection of patients will depend solely on the facility conversion date on a first-come first-served basis All patients within the dialysis facility that provide blood specimen for their routine monthly lab draws will be eligible The facilities and patients will be enrolled consecutively until the desired sample size of approximately 2500 patients is reached
Detailed Description:
The proposed project is an ancillary quality improvement study that intends to prospectively track serum markers of inflammation C-reactive protein or CRP and nutrition pre-albumin at baseline within 2-months before conversion from reuse to single use of dialyzers and at the end of a 6-month follow-up period after the conversion in maintenance hemodialysis patients The first 2500 patients from a potential pool of 2900 patients from 48 dialysis units that are scheduled to convert from reuse to single use of dialyzers will be included in the study Apart from routine monthly laboratory measurements the investigators in collaboration with Spectra Laboratories central lab will perform measurements of CRP and pre-albumin on the excess blood after all the routine blood chemistries have been obtained from the patients selected to be part of the study cohort It is anticipated that the nature of this study as a quality improvement project with no additional burden to the patients since tests will only be performed on excess blood from samples already sent to the laboratory and the utilization of the information only in aggregate with no identifiable personal health information will allow for this study to proceed without the need for informed consent from each individual patient It is hypothesized that the survival benefit that has been observed in some epidemiological studies including the prior experience at Fresenius Medical Care North America may be accompanied by andor the result of reduced inflammation andor improvement of nutritional status in patients that are converted from reuse to single use of dialyzers The study will compare the difference between the values of CRP and pre-albumin separately at baseline and at the end of 6-months after the conversion CRP levels are expected to decline while pre-albumin are expected to increase during the follow-up period Even with a 20 dropout rate the study is expected to have 90 power to detect a change in CRP of 3 mgL and 99 power to detect a similar change in pre-albumin The patients in this study are only a subset of a larger epidemiological study that will examine the impact of converting from reuse to single use of dialyzers on patient survival
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