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

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ClinicalTrials.gov Identifier: NCT00858390
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : June 16, 2014
Last Update Posted : June 26, 2014
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

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Brain Death Dietary Supplement: enteral feeding with Oxepa® and Glutasolve® Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Interventions to Increase Organ Procurement Nutritional Status and Enteral Absorption Capability After Brain Death (R38OT10585)
Study Start Date : February 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1 standard care
organ donors receiving standard care
Experimental: 2 Enteral Feeding
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
 Dietary Supplement: enteral feeding with Oxepa® and Glutasolve®
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858390


Locations
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United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Health Resources and Services Administration (HRSA)
Baylor College of Medicine
LifeGift
Investigators
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Principal Investigator: Georgene Hergenroeder, MHA, RN The University of Texas Health Science Center, Houston
More Information
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Publications of Results:

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Responsible Party: Georgene Hergenroeder, Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00858390    
Other Study ID Numbers: R38OT10585
R38OT10585
HSC-MS-08-0473
First Posted: March 9, 2009    Key Record Dates
Results First Posted: June 16, 2014
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Brain Death
Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations