End Stage Renal DiseaseNCT00440908
Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers
An observational study of End Stage Renal Disease and Inflammation, run by Fresenius Medical Care North America at 2 sites in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Inflammation
- How many people
- 2,500 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients receiving dialysis in facilities where re-use of dialyzers processed with Renalin is practiced
Who may be able to join
- 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.
Who cannot join
- Hemodialysis patients not currently reusing reprocessed dialyzers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fresenius Medical Care North America
Waltham, Massachusetts, 02145
Fresenius Medical Care North America
Waltham, Massachusetts, 02451
About this study
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
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
Read the 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 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.
- Conditions
- End Stage Renal Disease, Inflammation
- Keywords
- Dialyzer reuse, Inflammatory markers, Nutritional status
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raymond Hakim, MD, PhD, Principal investigator, Fresenius Medical Care North AmericaEduardo Lacson, MD, MPH, Study director, Fresenius Medical Care North America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440908
- Sponsor's protocol ID
- 07-032
- Status last verified
- May 2008
- First submitted
- 26 Feb 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lowrie EG, Li Z, Ofsthun N, Lazarus JM. Reprocessing dialysers for multiple uses: recent analysis of death risks for patients. Nephrol Dial Transplant. 2004 Nov;19(11):2823-30. doi: 10.1093/ndt/gfh460. Epub 2004 Aug 17.
PubMed 15316099
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00440908
- Acronym / sponsor ID
- 07-032
- Conditions
- End Stage Renal Disease, Inflammation
- Keywords
- Dialyzer reuse, Inflammatory markers, Nutritional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving dialysis in facilities where re-use of dialyzers processed with Renalin is practiced
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Hemodialysis patients not currently reusing reprocessed dialyzers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
- Background: PubMed 15316099Lowrie EG, Li Z, Ofsthun N, Lazarus JM. Reprocessing dialysers for multiple uses: recent analysis of death risks for patients. Nephrol Dial Transplant. 2004 Nov;19(11):2823-30. doi: 10.1093/ndt/gfh460. Epub 2004 Aug 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Hakim, MD, PhD principal investigator
Fresenius Medical Care North America
Eduardo Lacson, MD, MPH study director
Fresenius Medical Care North America
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Inflammation, run by Fresenius Medical Care North America at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008.