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Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Primary Purpose

Enteral Feeding

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hypocaloric feeding
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enteral Feeding focused on measuring Indirect calorimetry, hypocaloric feeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anticipated Mechanical ventilation for at least 72 hrs.
  • Need for enteral feeding
  • men and woman aged 18 or older.

Exclusion Criteria:

  • Abdominal surgery with inability to feed enterally.
  • FiO2 greater than 80%
  • Bronchopleural fistula
  • Hemodynamic instability in spite the use of vassopressors.

Sites / Locations

  • Wolfson MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Hypocaloric feeding group

Full energy feeding group

Arm Description

intervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.

Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 100% of REE will be provided.

Outcomes

Primary Outcome Measures

All cause mortality, ICU mortality, Hospital mortality.
All cause mortality, ICU mortality, Hospital mortality.

Secondary Outcome Measures

ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,

Full Information

First Posted
August 13, 2012
Last Updated
August 14, 2012
Sponsor
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01665664
Brief Title
Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients
Official Title
Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.
Detailed Description
Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding
Keywords
Indirect calorimetry, hypocaloric feeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypocaloric feeding group
Arm Type
Other
Arm Description
intervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
Arm Title
Full energy feeding group
Arm Type
No Intervention
Arm Description
Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 100% of REE will be provided.
Intervention Type
Other
Intervention Name(s)
Hypocaloric feeding
Other Intervention Name(s)
trophic group
Intervention Description
Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
Primary Outcome Measure Information:
Title
All cause mortality, ICU mortality, Hospital mortality.
Description
All cause mortality, ICU mortality, Hospital mortality.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
Description
ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anticipated Mechanical ventilation for at least 72 hrs. Need for enteral feeding men and woman aged 18 or older. Exclusion Criteria: Abdominal surgery with inability to feed enterally. FiO2 greater than 80% Bronchopleural fistula Hemodynamic instability in spite the use of vassopressors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arie Soroksky, M.D.
Phone
972-50-4056787
Email
soroksky@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Soroksky, MD
Organizational Affiliation
Wolfson MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson MC
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arie Soroksky, MD
Phone
972-50-4056787
Email
soroksky@gmail.com
First Name & Middle Initial & Last Name & Degree
Arie Soroksky, MD

12. IPD Sharing Statement

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Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

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