Timing of Target Enteral Feeding in the Mechanically Vent... | NCT00252616

Studies
Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

NCT00252616

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Dec 17, 2013Estimated

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Acute Respiratory Failure

Interventions

trophic enteral feeds

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

Dec 2013

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

Sep 2003

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Nov 9, 2005

First Submission Date that Met QC Criteria

Nov 10, 2005

First Posted Date

Nov 11, 2005Estimated

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

Dec 16, 2013

Last Update Posted Date

Dec 17, 2013Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.

Detailed Description

Mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. Primary endpoints are ventilator free days, ICU-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.

Design Module

Study Type

Interventional

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	trophic feeds	Behavioral: trophic enteral feeds
2	Active Comparator	Full-calorie feeds	Behavioral: trophic enteral feeds

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trophic enteral feeds	Behavioral	10cc/hr	1 2

Measure	Description	Time Frame
Ventilator-free days		day 28

Measure	Description	Time Frame
ICU-free days		day 28
Mortality		28 days
Incidence of Gastrointestinal intolerances

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients will be eligible for inclusion in the study if they meet the following criteria:

Mechanical ventilation expected to last at least 72 hours.
Presence of, or primary physician's intent to place, an enteral feeding tube and begin enteral feeds.

Exclusion Criteria:

More than 48 hours elapsed since both inclusion criteria met.
Patient, legal representative, or physician refuses consent or is unavailable to provide consent.
Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%.
Severe or refractory shock.
Moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team).
Child-Pugh score greater than 10.
Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction.
Current TPN use or intent to use TPN within 7 days.
Severe malnutrition with BMI less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months.
Neuromuscular disease impairing the ability to ventilate spontaneously.
Laparotomy expected within 7 days.
Unable to raise head of bed 45°.
greater than 30% total body surface area burns.
Absence of GI tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less.
Presence of high-output (> 500 cc/day) enterocutaneous fistula.
Age less than 13 years
Allergy to enteral formula

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Todd W Rice, MD, MSc	Vanderbilt University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21242788	Derived	Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.