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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
  Purpose

This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.


Condition Intervention
Critical Illness
Obesity
Other: enteral formula

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enteral Formula Tolerance in the Obese Critical Care Population

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • time to feeding goal achievement [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    on all participants


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 26
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

critically ill obese adults

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357200

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01357200     History of Changes
Other Study ID Numbers: 10.02.US.CLI
Study First Received: May 15, 2011
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014