Nutritional Status and Enteral Absorption Capability After Brain Death

Brain Death Clinical Trial

— HRSA Nutrition  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858390
• Other study ID #: R38OT10585
• Secondary ID: R38OT10585HSC-MS
• Status: Completed
• Phase: N/A
• First received: March 6, 2009
• Last updated: June 13, 2014
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Death
• Death

Intervention

Dietary Supplement:
• enteral feeding with Oxepa® and Glutasolve®
enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baylor College of Medicine, Health Resources and Services Administration (HRSA), LifeGift

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12+/-2 hours	No