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Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Sponsor
Wolfson Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01665664
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
13
Duration (Months)
15.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypocaloric feeding
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
Study Start Date :
Sep 1, 2012
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Hypocaloric feeding group

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.

Other: Hypocaloric feeding
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.
Other Names:
  • trophic group

    		•
    No Intervention: Full energy feeding group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality, ICU mortality, Hospital mortality. [1 year]

      All cause mortality, ICU mortality, Hospital mortality.

    Secondary Outcome Measures

    1. ICU and Hospital LOS, Length of mechanical ventilation, rate of infections, [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wolfson MC Holon Israel 58100

    Sponsors and Collaborators

    • Wolfson Medical Center

    Investigators

    • Principal Investigator: Arie Soroksky, MD, Wolfson MC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soroksky Arie, M.D., Wolfson Medical Center
    ClinicalTrials.gov Identifier:
    NCT01665664
    Other Study ID Numbers:
    • 0014-12-WOMC
    First Posted:
    Aug 15, 2012
    Last Update Posted:
    Aug 15, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Soroksky Arie, M.D., Wolfson Medical Center
    Indirect calorimetry
    hypocaloric feeding
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Aug 15, 2012