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Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01665664
Recruitment Status : Unknown
Verified August 2012 by Soroksky Arie, Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center

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
Enteral Feeding Other: Hypocaloric feeding Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Arm Intervention/treatment
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 Name: 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.



Primary Outcome Measures :
  1. All cause mortality, ICU mortality, Hospital mortality. [ Time Frame: 1 year ]
    All cause mortality, ICU mortality, Hospital mortality.


Secondary Outcome Measures :
  1. ICU and Hospital LOS, Length of mechanical ventilation, rate of infections, [ Time Frame: 1 year ]
    ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665664


Contacts
Contact: Arie Soroksky, M.D. 972-50-4056787 soroksky@gmail.com

Locations
Israel
Wolfson MC Not yet recruiting
Holon, Israel, 58100
Contact: Arie Soroksky, MD    972-50-4056787    soroksky@gmail.com   
Principal Investigator: Arie Soroksky, MD         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Arie Soroksky, MD Wolfson MC

Responsible Party: Soroksky Arie, M.D., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01665664     History of Changes
Other Study ID Numbers: 0014-12-WOMC
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Soroksky Arie, Wolfson Medical Center:
Indirect calorimetry
hypocaloric feeding

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes