Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Enteral Feeding

Intervention / Treatment
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* Other: Hypocaloric feeding


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hypocaloric feeding group<br>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<br>* 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.<br>* Other names: trophic group;|
| No Intervention: Full energy feeding group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indirect calorimetry, hypocaloric feeding