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

Primary Purpose

Brain Death

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
enteral feeding with Oxepa® and Glutasolve®
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Death

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

  • Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1 standard care

2 Enteral Feeding

Arm Description

organ donors receiving standard care

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 6, 2009
Last Updated
June 13, 2014
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Health Resources and Services Administration (HRSA), Baylor College of Medicine, LifeGift
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1. Study Identification

Unique Protocol Identification Number
NCT00858390
Brief Title
Nutritional Status and Enteral Absorption Capability After Brain Death
Acronym
HRSA Nutrition
Official Title
Clinical Interventions to Increase Organ Procurement Nutritional Status and Enteral Absorption Capability After Brain Death (R38OT10585)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Health Resources and Services Administration (HRSA), Baylor College of Medicine, LifeGift

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 standard care
Arm Type
No Intervention
Arm Description
organ donors receiving standard care
Arm Title
2 Enteral Feeding
Arm Type
Experimental
Arm Description
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
Intervention Type
Dietary Supplement
Intervention Name(s)
enteral feeding with Oxepa® and Glutasolve®
Intervention Description
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
Primary Outcome Measure Information:
Title
Primary Outcome Measure is IL-6 Level
Description
Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.
Time Frame
12+/-2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgene Hergenroeder, MHA, RN
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24311403
Citation
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.
Results Reference
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Nutritional Status and Enteral Absorption Capability After Brain Death

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