Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Enteral Feeding
• Intervention / Treatment: Other: Hypocaloric feeding

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
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arie Soroksky, M.D.; Phone Number: 972-50-4056787; Email: soroksky@gmail.com

Study Locations

• Israel
  • Holon, Israel, 58100
    • Wolfson MC
    • Principal Investigator: Arie Soroksky, MD
    • Contact: Arie Soroksky, MD; Phone Number: 972-50-4056787; Email: soroksky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality, ICU mortality, Hospital mortality.	All cause mortality, ICU mortality, Hospital mortality.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,	ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,	1 year

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Arie Soroksky, MD, Wolfson MC

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: hypocaloric feeding; Indirect calorimetry
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 0014-12-WOMC