Text Size

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
  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:

U.S. FDA Resources

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


Estimated Enrollment: 25
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357200

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Karen Beatty, RN     502-813-6564     karen.beatty@louisville.edu    
Principal Investigator: Stephen McClave, MD            
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Stephen McClave, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT01357200     History of Changes
Other Study ID Numbers: 10.02.US.CLI
Study First Received: May 15, 2011
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Obesity
Disease Attributes
Pathologic Processes
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013