Feeding Trial in the Obese Critical Care Population
Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT01357200
Collaborator
(none)
26
2
31
13
0.4
Study Details
Study Description
Brief Summary
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.
Study Design
Study Type:
Observational
Actual Enrollment
:
26 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Enteral Formula Tolerance in the Obese Critical Care Population
Study Start Date
:
May 1, 2011
Actual Primary Completion Date
:
Dec 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| critically ill obese adults Age ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days |
Other: enteral formula
Complete feeding of study enteral formula, route and regime prescribed by the physician.
|
Outcome Measures
Primary Outcome Measures
- time to feeding goal achievement [up to 5 days]
on all participants
Secondary Outcome Measures
- gastrointestinal measures assessment [daily for up to 11 days]
on all participants
- percent of nutrition goal met [up to 5 days]
on all participants
- serum biochemical markers assessment [daily for up to 11 days]
on all participants
- assessment of frequency and nature of adverse events [daily for up to 11 days]
on all participants
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥ 18 years
-
Surgical or Medical intensive care unit (ICU) patient
-
Body mass index (BMI) ≥ 30
Exclusion Criteria:
-
pregnant or lactating
-
unable to access gastrointestinal (GI) tract for feeding via tube
-
other contraindication to tube feeding
-
admitted with burns
-
severe head trauma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 2 | University of Louisville | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- Nestlé
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT01357200
Other Study ID Numbers:
- 10.02.US.CLI
First Posted:
May 20, 2011
Last Update Posted:
Jan 30, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms: