NCT01357200

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

2.6 years

First QC Date

May 15, 2011

Last Update Submit

January 29, 2014

Conditions

Critical IllnessObesity

Outcome Measures

Primary Outcomes (1)

  • time to feeding goal achievement

    on all participants

    up to 5 days

Secondary Outcomes (4)

  • gastrointestinal measures assessment

    daily for up to 11 days

  • percent of nutrition goal met

    up to 5 days

  • serum biochemical markers assessment

    daily for up to 11 days

  • assessment of frequency and nature of adverse events

    daily for up to 11 days

Study Arms (1)

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

Interventions

enteral formulaOTHER

Complete feeding of study enteral formula, route and regime prescribed by the physician.

critically ill obese adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

critically ill obese adults

You may qualify if:

  • Age ≥ 18 years
  • Surgical or Medical intensive care unit (ICU) patient
  • Body mass index (BMI) ≥ 30

You may not qualify if:

  • pregnant or lactating
  • unable to access gastrointestinal (GI) tract for feeding via tube
  • other contraindication to tube feeding
  • admitted with burns
  • severe head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Critical IllnessObesity

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2011

First Posted

May 20, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

US(2)