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| ID | Type | Description | Link |
|---|---|---|---|
| R38OT10585 | |||
| HSC-MS-08-0473 |
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| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
| Baylor College of Medicine | OTHER |
| LifeGift | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 standard care | No Intervention | organ donors receiving standard care | |
| 2 Enteral Feeding | Experimental | enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral feeding with Oxepa® and Glutasolve® | Dietary Supplement | enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgene Hergenroeder, MHA, RN | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24311403 | Result | 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. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Standard Care | 18 organ donors receiving standard care |
| FG001 | 2 Enteral Feeding | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Standard Care | 18 organ donors receiving standard care |
| BG001 | 2 Enteral Feeding | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pg/ml | 12+/-2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Standard Care | 18 organ donors receiving standard care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G Hergenroeder, Principal Investigator | The University of Texas Health Science Center at Houston | 7135006130 | Georgene.W.Hergenroeder@uth.tmc.edu |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Organs procured | Mean | Standard Deviation | Solid organs procured |
|
| Organs Transplanted | Mean | Standard Deviation | Solid organs transplanted |
|
| Positive Breath Test Results | An exhaled gas concentration of 9% cumulative percent dose recovery was defined as assimilating the 13C-uracil and therefore a positive breath test. | Number | participants |
|
| Resting energy expenditure | Mean | Standard Deviation | kcal/d |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 2 Enteral Feeding | 18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE® | 0 | 18 | 0 | 18 |
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.
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |