- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440908
Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers
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
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:
- In patients with baseline CRP > 5 mg/L: Mean decrease of 5 mg/L
- In patients with baseline CRP < 5 mg/L: > 95% will remain < 5 mg/L
- Mean serum pre-albumin levels will increase by at least 3 mg/dL. The study population will be drawn from ~2,900 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 2,500 patients is reached
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Waltham, Massachusetts, United States, 02145
- Fresenius Medical Care North America
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Waltham, Massachusetts, United States, 02451
- Fresenius Medical Care North America
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing hemodialysis in 48 dialysis units that have been identified as continuing to reuse dialyzers processed with peracetic acid-based disinfectant (Renalin®), as of February 1, 2007.
Exclusion Criteria:
- Hemodialysis patients not currently reusing reprocessed dialyzers
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
Investigators
- Principal Investigator: Raymond Hakim, MD, PhD, Fresenius Medical Care North America
- Study Director: Eduardo Lacson, MD, MPH, Fresenius Medical Care North America
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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