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

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Baylor College of Medicine
LifeGift
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00858390
First received: March 6, 2009
Last updated: June 13, 2014
Last verified: June 2014

March 6, 2009
June 13, 2014
February 2009
August 2012   (final data collection date for primary outcome measure)
Primary Outcome Measure is IL-6 Level [ Time Frame: 12+/-2 hours ] [ Designated as safety issue: No ]
Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.
Primary outcome measure is IL-6 level [ Time Frame: 12+/-2 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00858390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nutritional Status and Enteral Absorption Capability After Brain Death
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Death
Dietary Supplement: enteral feeding with Oxepa® and Glutasolve®
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
  • No Intervention: 1 standard care
    organ donors receiving standard care
  • Experimental: 2 Enteral Feeding
    enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
    Intervention: Dietary Supplement: enteral feeding with Oxepa® and Glutasolve®
Hergenroeder GW, Ward NH, Yu X, Opekun A, Moore AN, Kozinetz CA, Powner DJ. Randomized trial to evaluate nutritional status and absorption of enteral feeding after brain death. Prog Transplant. 2013 Dec;23(4):374-82. doi: 10.7182/pit2013996.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2013
August 2012   (final data collection date for primary outcome measure)

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%
Both
14 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00858390
R38OT10585, R38OT10585, HSC-MS-08-0473
Yes
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
  • Health Resources and Services Administration (HRSA)
  • Baylor College of Medicine
  • LifeGift
Principal Investigator: Georgene Hergenroeder, MHA, RN The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP