Feeding Trial in the Obese Critical Care Population

This study is currently recruiting participants.

Verified June 2011 by Nestlé

Sponsor:

Information provided by:

Nestlé

ClinicalTrials.gov Identifier:

NCT01357200

First received: May 15, 2011

Last updated: June 3, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 15, 2011
Last Updated Date	June 3, 2011
Start Date ^ICMJE	May 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 18, 2011)	time to feeding goal achievement [ Time Frame: up to 5 days ] [ Designated as safety issue: No ] on all participants
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01357200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 3, 2011)	gastrointestinal measures assessment [ Time Frame: daily for up to 11 days ] [ Designated as safety issue: No ] on all participants percent of nutrition goal met [ Time Frame: up to 5 days ] [ Designated as safety issue: No ] on all participants serum biochemical markers assessment [ Time Frame: daily for up to 11 days ] [ Designated as safety issue: No ] on all participants assessment of frequency and nature of adverse events [ Time Frame: daily for up to 11 days ] [ Designated as safety issue: No ] on all participants
Original Secondary Outcome Measures ^ICMJE (submitted: May 18, 2011)	gastrointestinal measures assessment [ Time Frame: daily ] [ Designated as safety issue: No ] on all participants percent of nutrition goal met [ Time Frame: up to 5 days ] [ Designated as safety issue: No ] on all participants serum biochemical markers assessment [ Time Frame: daily ] [ Designated as safety issue: No ] on all participants assessment of frequency and nature of adverse events [ Time Frame: daily ] [ Designated as safety issue: No ] on all participants
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feeding Trial in the Obese Critical Care Population
Official Title ^ICMJE	Enteral Formula Tolerance in the Obese Critical Care Population
Brief Summary	This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.
Detailed Description	Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: serum
Sampling Method	Probability Sample
Study Population	critically ill obese adults
Condition ^ICMJE	Critical Illness Obesity
Intervention ^ICMJE	Other: enteral formula Complete feeding of study enteral formula, route and regime prescribed by the physician.
Study Group/Cohort (s)	critically ill obese adults Age ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days Intervention: Other: enteral formula
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	25
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01357200
Other Study ID Numbers ^ICMJE	10.02.US.CLI
Has Data Monitoring Committee	No
Responsible Party	Stephen McClave, MD, University of Louisville
Study Sponsor ^ICMJE	Nestlé
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nestlé
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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