Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2012
CompletedFirst Posted
Study publicly available on registry
August 15, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 15, 2012
August 1, 2012
1 year
August 13, 2012
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality, ICU mortality, Hospital mortality.
All cause mortality, ICU mortality, Hospital mortality.
1 year
Secondary Outcomes (1)
ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
1 year
Study Arms (2)
Hypocaloric feeding group
OTHERintervention - 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.
Full energy feeding group
NO INTERVENTIONDaily 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Anticipated Mechanical ventilation for at least 72 hrs.
- Need for enteral feeding
- men and woman aged 18 or older.
You may not qualify if:
- Abdominal surgery with inability to feed enterally.
- FiO2 greater than 80%
- Bronchopleural fistula
- Hemodynamic instability in spite the use of vassopressors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wolfson MC
Holon, 58100, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Arie Soroksky, MD
Wolfson MC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 13, 2012
First Posted
August 15, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
August 15, 2012
Record last verified: 2012-08