HRSA Nutrition: Nutritional Status and Enteral Absorption Capability After Brain Death
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Primary Outcome Measure is IL-6 Level [12+/-2 hours]
Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.
Eligibility Criteria
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%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Georgene Hergenroeder, MHA, RN, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R38OT10585
- R38OT10585
- HSC-MS-08-0473
Study Results
Participant Flow
| Recruitment Details | Thirty-six (36) brain dead organ donors were randomized in a 1:1 ratio to standard care (fasting) or to receive the nutritional intervention via naso/oro-duodenal feeding. Consent was obtained from family members for subject participation. Organ donors were screened and enrolled between 2/2009-6/2011. |
|---|---|
| Pre-assignment Detail | Inclusion criteria: consented brain-dead organ donors age 14 to 70 years; may have received parenteral/enteral nutrition prior, but were excluded for prior gastric/bowel resections, GI malabsorption, bariatric procedures, vagotomy, pyloroplasty, or pancreatitis. Donors were excluded if a FiO2 greater than 60% was required (REE). |
| Arm/Group Title | 1 Standard Care | 2 Enteral Feeding |
|---|---|---|
| Arm/Group Description | 18 organ donors receiving standard care | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® |
| Period Title: Overall Study | ||
| STARTED | 18 | 18 |
| COMPLETED | 18 | 18 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 1 Standard Care | 2 Enteral Feeding | Total |
|---|---|---|---|
| Arm/Group Description | 18 organ donors receiving standard care | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® | Total of all reporting groups |
| Overall Participants | 18 | 18 | 36 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.5
(14.7)
|
38.9
(14.5)
|
41.9
(14.7)
|
| Age (Count of Participants) | |||
| <=18 years |
2
11.1%
|
2
11.1%
|
4
11.1%
|
| Between 18 and 65 years |
15
83.3%
|
15
83.3%
|
30
83.3%
|
| >=65 years |
1
5.6%
|
1
5.6%
|
2
5.6%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
22.2%
|
7
38.9%
|
11
30.6%
|
| Male |
14
77.8%
|
11
61.1%
|
25
69.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
5.6%
|
0
0%
|
1
2.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
5.6%
|
1
2.8%
|
| White |
17
94.4%
|
17
94.4%
|
34
94.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
10
55.6%
|
5
27.8%
|
15
41.7%
|
| Not Hispanic or Latino |
8
44.4%
|
13
72.2%
|
21
58.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
18
100%
|
18
100%
|
36
100%
|
| Organs procured (Solid organs procured) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Solid organs procured] |
4.6
(1.5)
|
4.4
(4.0)
|
4.53
(1.7)
|
| Organs Transplanted (Solid organs transplanted) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Solid organs transplanted] |
3.5
(1.8)
|
4.1
(2.1)
|
3.8
(2)
|
| Positive Breath Test Results (participants) [Number] | |||
| Number [participants] |
4
22.2%
|
6
33.3%
|
10
27.8%
|
| Resting energy expenditure (kcal/d) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kcal/d] |
1954
(691.9)
|
1773
(778.8)
|
1866
(729.5)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1 Standard Care | 2 Enteral Feeding |
|---|---|---|
| Arm/Group Description | 18 organ donors receiving standard care | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® |
| Measure Participants | 18 | 18 |
| Mean (Standard Deviation) [pg/ml] |
565.5
(1010)
|
264.9
(285.6)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | 1 Standard Care | 2 Enteral Feeding | ||
| Arm/Group Description | 18 organ donors receiving standard care | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® | ||
All Cause Mortality |
||||
| 1 Standard Care | 2 Enteral Feeding | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| 1 Standard Care | 2 Enteral Feeding | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/18 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| 1 Standard Care | 2 Enteral Feeding | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/18 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
This work was supported by the Department of Health and Human Services Health Resources and Services Administration Award Number 1R38OT10585-01-00 and, in part, by Public Health Service Grant DK56338. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the PHS or HHS.
Results Point of Contact
| Name/Title | G Hergenroeder, Principal Investigator |
|---|---|
| Organization | The University of Texas Health Science Center at Houston |
| Phone | 7135006130 |
| Georgene.W.Hergenroeder@uth.tmc.edu |
- R38OT10585
- R38OT10585
- HSC-MS-08-0473