NCT00858390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 16, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

3.5 years

First QC Date

March 6, 2009

Results QC Date

May 15, 2014

Last Update Submit

June 13, 2014

Conditions

Brain Death

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1 standard care

NO INTERVENTION

organ donors receiving standard care

2 Enteral Feeding

EXPERIMENTAL

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Dietary Supplement: enteral feeding with Oxepa® and Glutasolve®

Interventions

enteral feeding with Oxepa® and Glutasolve®DIETARY_SUPPLEMENT

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

2 Enteral Feeding

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consented solid organ donor
  • Age \>14, \<65 years old
  • Donors may have received or are receiving parenteral or enteral nutrition

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related 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.

    PMID: 24311403RESULT

MeSH Terms

Conditions

Brain Death

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Results Point of Contact

Title
G Hergenroeder, Principal Investigator
Organization
The University of Texas Health Science Center at Houston
Georgene.W.Hergenroeder@uth.tmc.edu
7135006130

Study Officials

  • Georgene Hergenroeder, MHA, RN

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Neurosurgery

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2012

Study Completion

December 1, 2013

Last Updated

June 26, 2014

Results First Posted

June 16, 2014

Record last verified: 2014-06

Locations

US(1)