Feeding Trial in the Obese Critical Care Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01357200
First received: May 15, 2011
Last updated: January 29, 2014
Last verified: January 2014

May 15, 2011
January 29, 2014
May 2011
December 2013   (final data collection date for primary outcome measure)
time to feeding goal achievement [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
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 ] [ 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
  • 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
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01357200
10.02.US.CLI
No
Nestlé
Nestlé
Not Provided
Not Provided
Nestlé
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP