Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers

2014-08-27 03:39:56 | BioPortfolio


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


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


End Stage Renal Disease


Fresenius Medical Care North America
United States




Fresenius Medical Care North America

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:39:56-0400

Clinical Trials [2566 Associated Clinical Trials listed on BioPortfolio]

Registry for End Stage Renal Failure

The rein registry collects case record data from patients with end stage renal disease followed in French Guiana. This allows to generate incidence and rates for terminal renal disease, mo...

Native Kidney Denervation in Patients With End Stage Renal Disease

To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).

Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease

Family Meeting Study for End Stage Renal Disease

A randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital re...

Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease

In Egypt, the prevalence of end stage renal disease in pediatric population has never been estimated on a national scale. The patients at end stage renal disease encounter oral and dental ...

PubMed Articles [19666 Associated PubMed Articles listed on BioPortfolio]

The perspectives of patients with lithium-induced end-stage renal disease.

Lithium is the treatment of choice for patients suffering from bipolar disorder (BD) but prolonged use induces renal dysfunction in at least 20% of patient. Intensive monitoring of kidney functioning ...

Association Between Superoxide Dismutase Isoenzyme Gene Expression and Total Antioxidant Status in End-Stage Renal Disease Patients on Hemodialysis.

Chronic renal failure, especially end-stage renal disease is a serious health problem associated with high mortality rate. Uremic syndrome leads to increased oxidative stress, inflammation and dyslipi...

Consumption of Coffee but Not of Other Caffeine-Containing Beverages Reduces the Risk of End-Stage Renal Disease in the Singapore Chinese Health Study.

Cross-sectional studies suggest that coffee drinking is associated with better renal function. However, to our knowledge, no prospective study has examined its relation with the risk of end-stage rena...

Discordance in latent tuberculosis (TB) test results in patients with end-stage renal disease.

This natural experiment was designed to assess the impact of exposure to an active case of tuberculosis (TB) on a group of immunosuppressed individuals, with end-stage renal disease over an extended f...

Total Renal Care Approach for Patients with End-Stage Renal Disease.

Advances in dialysis medicine have enabled end-stage renal disease (ESRD) patients to live longer. ESRD patients and their family members experience the illness in everyday life, and patients are requ...

Medical and Biotech [MESH] Definitions

Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

Functional KIDNEY FAILURE in patients with liver disease, usually LIVER CIRRHOSIS or portal hypertension (HYPERTENSION, PORTAL), and in the absence of intrinsic renal disease or kidney abnormality. It is characterized by intense renal vasculature constriction, reduced renal blood flow, OLIGURIA, and sodium retention.

Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.

KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE.

The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.

More From BioPortfolio on "Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers"

Quick Search


Relevant Topics

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Searches Linking to this Trial