Nutritional Status and Enteral Absorption Capability After Brain Death (HRSA Nutrition)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Brain Death

Treatments

Dietary Supplement: enteral feeding with Oxepa® and Glutasolve®

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00858390
R38OT10585
HSC-MS-08-0473

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

14 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Consented solid organ donor
  2. Age >14, <65 years old
  3. Donors may have received or are receiving parenteral or enteral nutrition

Exclusion criteria

  1. Known gastric or small bowel resections
  2. Known malabsorptive disease of the gastrointestinal tract
  3. Bariatric procedures, vagotomy or pyloroplasty
  4. Known acute or chronic pancreatitis
  5. Requiring an FiO2 > 60%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

1 standard care
No Intervention group
Description:
organ donors receiving standard care
2 Enteral Feeding
Experimental group
Description:
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
Treatment:
Dietary Supplement: enteral feeding with Oxepa® and Glutasolve®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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