Optimized Caloric-proteic Nutrition in Critically Ill Patients

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03060668
Study type	Interventional
Source	Hospital Sao Domingos
Contact
Status	Completed
Phase	N/A
Start date	June 2016
Completion date	December 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.