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Completed

NCT Number: NCT00858390

Nutritional Status and Enteral Absorption Capability After Brain Death

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.

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known gastric or small bowel resections
  • Known malabsorptive disease of the gastrointestinal tract
  • Bariatric procedures, vagotomy or pyloroplasty
  • Known acute or chronic pancreatitis
  • Requiring an FiO2 > 60%

Treatment and study plan

enteral feeding with Oxepa® and Glutasolve®

Dietary Supplement

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Primary outcomes

  1. Primary Outcome Measure is IL-6 Level

    Time frame: 12+/-2 hours

    Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Baylor College of Medicine
  • Health Resources and Services Administration (HRSA)
  • LifeGift

Registry information

Official study title

Clinical Interventions to Increase Organ Procurement Nutritional Status and Enteral Absorption Capability After Brain Death (R38OT10585)

Acronym: HRSA Nutrition

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 9, 2009
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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