Nutritional Status and Enteral Absorption Capability After Brain Death
Condition: Brain Death
MeSH terms: Brain Death; Death
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): enteral feeding with Oxepa® and Glutasolve®
Intervention type(s): Dietary Supplement
Intervention description(s): enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment