Brain Death Clinical Trial
Official title:
Clinical Interventions to Increase Organ Procurement Nutritional Status and Enteral Absorption Capability After Brain Death (R38OT10585)
The investigators propose to assess 36 donors' nutritional status using accepted parameters (prealbumin, resting energy expenditure); to assess nutrient intestinal absorption through 13Curacil breath tests; and to evaluate serum concentrations of IL-6 and TNFalpha to determine if continuing or initiating enteral feeding and nutritional supplementation is effective in restoring or maintaining nutritional parameters.
There are an estimated 98,000 people in need of organ transplants in the United States
(OPTN). Only a fraction of the need is met with the organs that become available. Therefore
interventions are needed to maximize the viability of available organs and improve donor
organ procurement and successful transplantation.
Improving the nutritional status of potential donors after they are declared brain dead
could favorably impact subsequent organ procurement. Improved nutrition may improve organ
viability by reducing the negative effects of inflammatory cytokines and catecholamines, and
through reducing translocation of bacteria or endotoxin from the intestine.
In our preliminary work the investigators show significantly elevated inflammatory cytokines
(IL-6 and TNFalpha) in unfed donors and a correlation with improved graft survival in
recipients with lower plasma concentrations of IL-6.
The investigators propose to assess 36 donors' nutritional status using accepted parameters
(prealbumin, resting energy expenditure); to assess nutrient intestinal absorption through
13Curacil breath tests; and to evaluate serum concentrations of IL-6 and TNFalpha to
determine if continuing or initiating enteral feeding and nutritional supplementation is
effective in restoring or maintaining nutritional parameters. Additionally, half of the
group will be randomized to receive a nutritional supplement via naso/oro-duodenal feeding
tube with a commercially available formula containing omega-3 and omega-6 fatty acids, and
antioxidants plus glutamine (Oxepa® plus Glutasolve). The intervention through its
anti-inflammatory and antioxidant functions has the potential to improve organ function
(e.g. improved myocardial function (Wischmeyer 2003), and improved oxygenation (Pacht 2003;
Pontes-Arruda 2006; Singer 2006)). Through improved organ function and/or a suppression of
inflammatory cytokine production (e.g., IL-6 and TNFalpha) more organs are expected to be
appropriate for procurement/transplantation.
If enteral nutrition reduces the inflammatory response commonly documented after brain death
and, in doing so, improves organ procurement, enteral feeding could be immediately employed
toward improving donor care practices. Furthermore, reducing the level of inflammatory
molecules in donor organs may reduce the risk of rejection.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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