Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Wolfson Medical Center (WMC)

Status: Unknown

Conditions: Enteral Feeding

Treatments: Other: Hypocaloric feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT01665664

0014-12-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Hypocaloric feeding group

Other group

Description:

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.

Treatment:

Other: Hypocaloric feeding

Full energy feeding group

No Intervention group

Description:

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.