Trial Outcomes & Findings for Nutritional Status and Enteral Absorption Capability After Brain Death (NCT NCT00858390)
NCT ID: NCT00858390
Last Updated: 2014-06-26
Results Overview
Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
12+/-2 hours
Results posted on
2014-06-26
Participant Flow
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.
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).
Participant milestones
| Measure |
1 Standard Care
18 organ donors receiving standard care
|
2 Enteral Feeding
18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutritional Status and Enteral Absorption Capability After Brain Death
Baseline characteristics by cohort
| Measure |
1 Standard Care
n=18 Participants
18 organ donors receiving standard care
|
2 Enteral Feeding
n=18 Participants
18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Organs procured
|
4.6 Solid organs procured
STANDARD_DEVIATION 1.5 • n=5 Participants
|
4.4 Solid organs procured
STANDARD_DEVIATION 4.0 • n=7 Participants
|
4.53 Solid organs procured
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Organs Transplanted
|
3.5 Solid organs transplanted
STANDARD_DEVIATION 1.8 • n=5 Participants
|
4.1 Solid organs transplanted
STANDARD_DEVIATION 2.1 • n=7 Participants
|
3.8 Solid organs transplanted
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Positive Breath Test Results
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Resting energy expenditure
|
1954 kcal/d
STANDARD_DEVIATION 691.9 • n=5 Participants
|
1773 kcal/d
STANDARD_DEVIATION 778.8 • n=7 Participants
|
1866 kcal/d
STANDARD_DEVIATION 729.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12+/-2 hoursPlasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.
Outcome measures
| Measure |
1 Standard Care
n=18 Participants
18 organ donors receiving standard care
|
2 Enteral Feeding
n=18 Participants
18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
|
|---|---|---|
|
Primary Outcome Measure is IL-6 Level
|
565.5 pg/ml
Standard Deviation 1010
|
264.9 pg/ml
Standard Deviation 285.6
|
Adverse Events
1 Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Enteral Feeding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
G Hergenroeder, Principal Investigator
The University of Texas Health Science Center at Houston
Phone: 7135006130
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER