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Feeding Trial in the Obese Critical Care Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357200
First Posted: May 20, 2011
Last Update Posted: January 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
May 15, 2011
May 20, 2011
January 30, 2014
May 2011
December 2013   (Final data collection date for primary outcome measure)
time to feeding goal achievement [ Time Frame: up to 5 days ]
on all participants
Same as current
Complete list of historical versions of study NCT01357200 on ClinicalTrials.gov Archive Site
  • gastrointestinal measures assessment [ Time Frame: daily for up to 11 days ]
    on all participants
  • percent of nutrition goal met [ Time Frame: up to 5 days ]
    on all participants
  • serum biochemical markers assessment [ Time Frame: daily for up to 11 days ]
    on all participants
  • assessment of frequency and nature of adverse events [ Time Frame: daily for up to 11 days ]
    on all participants
  • gastrointestinal measures assessment [ Time Frame: daily ]
    on all participants
  • percent of nutrition goal met [ Time Frame: up to 5 days ]
    on all participants
  • serum biochemical markers assessment [ Time Frame: daily ]
    on all participants
  • assessment of frequency and nature of adverse events [ Time Frame: daily ]
    on all participants
Not Provided
Not Provided
 
Feeding Trial in the Obese Critical Care Population
Enteral Formula Tolerance in the Obese Critical Care Population
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.
Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
serum
Probability Sample
critically ill obese adults
  • Critical Illness
  • Obesity
Other: enteral formula
Complete feeding of study enteral formula, route and regime prescribed by the physician.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01357200
10.02.US.CLI
No
Not Provided
Not Provided
Nestlé
Nestlé
Not Provided
Not Provided
Nestlé
January 2014