Feeding Trial in the Obese Critical Care Population | NCT01357200

Studies
Feeding Trial in the Obese Critical Care Population

NCT01357200

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jan 30, 2014Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Critical Illness
Obesity

Interventions

enteral formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 15, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2014

Last Update Posted Date

Jan 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
enteral formula	Other	Complete feeding of study enteral formula, route and regime prescribed by the physician.	critically ill obese adults

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to feeding goal achievement	on all participants	up to 5 days

Secondary Outcomes

Measure	Description	Time Frame
gastrointestinal measures assessment	on all participants	daily for up to 11 days
percent of nutrition goal met	on all participants

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

critically ill obese adults

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40536	United States
University of Louisville

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D009765	Obesity

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided