Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Not Applicable

• Conditions: Enteral Feeding
• Interventions: Other: Hypocaloric feeding

• Registration Number: NCT01665664
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15
• Study Start: 2012-09
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypocaloric feeding group	Hypocaloric feeding	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.

Primary Outcome Measures

Name	Time	Method
All cause mortality, ICU mortality, Hospital mortality.	1 year	All cause mortality, ICU mortality, Hospital mortality.

Secondary Outcome Measures

Name	Time	Method
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,

Trial Locations

Locations (1)

Wolfson MC; 🇮🇱 Holon, Israel