Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers
Public ClinicalTrials.gov record NCT00440908. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00440908
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,500 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2007
- Primary completion
- Nov 30, 2007
- Completion
- Nov 30, 2007
- Last update posted
- May 6, 2008
2007
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fresenius Medical Care North America | Waltham | Massachusetts | 02145 | — |
| Fresenius Medical Care North America | Waltham | Massachusetts | 02451 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00440908, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2008 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00440908 live on ClinicalTrials.gov.