Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440908
• Other study ID #: 07-032
• Status: Completed
• Phase: N/A
• First received: February 26, 2007
• Last updated: May 6, 2008
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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 2,500 patients from a potential pool of ~2,900 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 and/or the result of, reduced inflammation and/or 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 mg/L 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Renal Disease
• Inflammation
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United States	Fresenius Medical Care North America	Waltham	Massachusetts
United States	Fresenius Medical Care North America	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reuse of hemodialyzers. American National Standard, Inc./ Association for the Advancement of Medical Instrumentation. ANSI/AAMI RD47, November 7, 2002 [Amended March 21, 2003] Lacson E Jr, Lazarus JM. Dialyzer best practice: single use or reuse? Semin Dial 19:120-128, 2006 Lowrie EG, Li Z, Ofsthun N, Lazarus JM: Reprocessing dialysers for multiple uses: recent analysis of death risks for patients. Nephrol Dial Transplant 19:2823-2830, 2004