Optimized Caloric-proteic Nutrition in Critically Ill Patients

Study Overview
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Brief Summary
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In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).

Detailed Description
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OBJECTIVES To evaluate the effect of nutritional therapy with caloric intake determined by indirect calorimetry and high protein intake (2.0 to 2.2 g/kg/day) compared to nutritional therapy with 25 kcal/kg/day and 1.4 to 1, 5 g/kg/day of protein on short-term outcomes and physical component (PCS) of quality of life after 3 and 6 months of randomization in severe ICU patients. The primary objective will be the evaluation of the physical component summary (PCS) of SF-36 (Short Form 36), a questionnaire used to evaluate quality of life, validated for the Brazilian population. Patients will be assessed at least 3 and 6 months after randomization. Secondary objectives: Measurement of handgrip strength measured on the 7th and 14th day of the study and on discharge from the ICU, ICU mortality, hospital mortality, mechanical ventilation time and length of stay in the ICU. METHODS The study will include patients over 18 years of age, not pregnant, submitted to mechanical ventilation, whose expectation of stay in the ICU is greater than 3 days. The sample size was calculated based on the following parameters: patient population under mechanical ventilation, 528, 15% relative risk reduction in the evaluation parameter of the SF-36 tool, Level of significance (α) of 5%, test power of 80%, thus the number of individuals to be sampled will be 294, i.e., two groups of 147 patients. A computer-generated list for randomization and sequentially numbered opaque sealed envelopes is used. The level of significance to reject the null hypothesis will be 5%, that is, a value of p <0.05 will be considered as statistically significant. Informed consent was obtained from the patient or a next of kin.

Official Title
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Optimized Caloric-proteic Nutrition in Critically Ill Patients: Impact on Short and Long-term Outcomes

Conditions
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Critically Ill

Intervention / Treatment
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* Other: Peptamen intense
* Other: Novasource senior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients Mechanically ventilated Expected length in the ICU > 3 days Exclusion Criteria: Pregnancy Requirement for inspired oxygen (FIO2) > 0.60 High output bronchopleural fistula

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Caloric needs will be determined by indirect calorimetry. Patients in this group will receive 2.0 to 2.2 grams/kg/day of protein. Nutritional therapy will be initiated in the first 24 hours after admission. Nutritional formula will be Peptamen Intense (1.0 kcal/ml, 93 g/L protein (Nestle Health Care). | Other: Peptamen intense<br>* Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein<br>|
| Active Comparator: Control Group<br>Patients in this group will receive 25 Kcal/kg/day and 1.4 to 1.5 grams/kg/day of protein. Nutritional formula in this group will be Novasource senior (Nestle Health Care). Nutritional therapy will be initiated in the first 24 hours after admission. | Other: Novasource senior<br>* Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCS of SF-36 | Physical component summary of Short Form 36 | 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | Measured using a calibrated dynamometer | 7th, 14th after admission and up to 30 days | 
| ICU mortality | ICU outcome | Up to 30 days | 
| Hospital mortality | Hospital outcome | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Illness, Indirect Calorimetry, Dietary Proteins