Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01665664
First received: August 13, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention
Enteral Feeding
Other: Hypocaloric feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • All cause mortality, ICU mortality, Hospital mortality. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    All cause mortality, ICU mortality, Hospital mortality.


Secondary Outcome Measures:
  • ICU and Hospital LOS, Length of mechanical ventilation, rate of infections, [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Soroksky Arie, M.D., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01665664     History of Changes
Other Study ID Numbers: 0014-12-WOMC
Study First Received: August 13, 2012
Last Updated: August 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
Indirect calorimetry
hypocaloric feeding

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014