Inflammation Clinical Trial
Official title:
Pilot/Feasibility Randomized Control Trial to Examine the Effect of Oral Nutritional Supplements With Anti-inflammatory/Anti-oxidative Properties and Pentoxiphylline on Malnutrition-inflammation-cachexia Syndrome in Maintenance Hemodialysis Patients
Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in maintenance hemodialysis patients
There are 350,000 hemodialysis patients in the USA; these are people who have end-stage
kiney disease and whose survival depends on thrice weekly hemodialysis treatment in a
dialysis clinic. Hemodialysis patients have an unacceptably high death rate, so that one out
of every 4 to 5 patients die each year. Almost half of all deaths are believed to be from
heart disease. Because markers of malnutrition and inflammation such as low amount of blood
protein (serum albumin <4.0 g/dL), rather than traditional risk factors, are among the
strongest predictors of early death and because malnutrition-inflammation appears to be
closely related to oxidative stress in hemodialysis patients, we would like to examine that
hypotesis that treating malnutrition-inflammation-oxidation by mean of nutritional support
may improve outcomes in them. Low serum albumin <4.0 g/dL is observed in almost half of all
hemodialysis patients and appears associated with low appetite, wasting, inflammation,
malfunction of the vessels, cardiovascular disease and several fold increase in mortality.
We hypothesize that the malnutrition-inflammation can be significantly corrected by a simple
in-center oral nutritional support with anti-inflammatory and antioxidant properties
combined with an appetite stimulant with anti-inflammatory properties, leading to improved
clinical and nutritional outcome measures in hemodialysis patients. We have proposed to the
National Institutes of Health a pilot/feasibility study where dialysis patients will have
50-50 chance of receiving real treatment or a fake version of it (placebo). This method is
called randomization, and this study type is called "randomized placebo-controlled clinical
trial" with two arms, a so-called 2x2 factorial design. Our proposed study has a low-priced
but efficient operational system and will be performed in 8 to 10 DaVita dialysis clinics in
Los Angles area. During this 2-year pilot/feasibility study, we will test whether our
proposed nutritional and anti-inflammatory treatments are safe and can improve low serum
albumin and other relevant outcomes in 100 hemodialysis patients. Subjects will be adult
hemodialysis patients with a serum albumin <4.0 g/dL.
The nutritional support arm will include a combination of 2 oral nutritional supplements;
i.e., Nepro™ (8 oz), tailored for malnourished hemodialysis patients; and a condensed
anti-inflammatory module similar to Oxepa™ (2 oz), designed for sick patients with
inflammation and oxidative stress; or their placebos. The appetite stimulating arm will
include a medication known as "pentoxifylline" (also known as Trental™) and the dose will be
400 mg daily or its placebo.
If a patient qualifies and agrees to participate in the study, there will be one month of
observations and tests, followed by 16 weeks of treatment, and then one additional month of
observation at the end. Both interventions are administered thrice weekly during routine
hemodialysis for 16 weeks. Nutritional, inflammatory and oxidative measures, vessel wall
(endothelial) function, quality of life and other clinical measures will be obtained before,
during, and after the intervention. The safety and tolerability of the treatments, the
feasibility of the study design, and the measurability of the outcomes will be examined.
We hope that the successful completion of this pilot/feasibility study in our campus leads
to design of a large-scale clinical trial at the national level to improve survival in
dialysis patients using nutritional and anti-inflammatory treatments.
Figure 1. Proposed pilot/feasibility study (see Appendix 1 for color version)
Group A (n=25) Nepro/Oxepa (2 cans) + PTX (400 mg) while on HD & the following day
Group B (n=25) Nepro/Oxepa (2 CANS) + placebo PTX while on HD& the following day
Group C (n=25) Placebo 2 cans + PTX (400 mg) while on HD& the following day
Group D (n=25) Placebo 2 cans + placebo PTX while on HD& the following day
PTX: pentoxifylline HD: Hemodialysis
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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