Feeding Trial in the Obese Critical Care Population

Completed

• Conditions: Critical Illness; Obesity
• Interventions: Other: enteral formula

• Registration Number: NCT01357200
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-15
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
critically ill obese adults	enteral formula	Age ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days

Primary Outcome Measures

Name	Time	Method
time to feeding goal achievement	up to 5 days	on all participants

Secondary Outcome Measures

Name	Time	Method
gastrointestinal measures assessment	daily for up to 11 days	on all participants
percent of nutrition goal met	up to 5 days	on all participants
assessment of frequency and nature of adverse events	daily for up to 11 days	on all participants
serum biochemical markers assessment	daily for up to 11 days	on all participants

Trial Locations

Locations (2)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States