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Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers

NCT00440908 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2008-05-07

No results posted yet for this study

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 mg/L: Mean decrease of 5 mg/L
2. In patients with baseline CRP \< 5 mg/L: \> 95% will remain \< 5 mg/L
3. 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

Conditions

Sponsors & Collaborators

  • Fresenius Medical Care North America

    lead INDUSTRY

Principal Investigators

  • Raymond Hakim, MD, PhD · Fresenius Medical Care North America

  • Eduardo Lacson, MD, MPH · Fresenius Medical Care North America

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440908 on ClinicalTrials.gov