Optimized Caloric-proteic Nutrition in Critically Ill Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Other: Peptamen intense; Other: Novasource senior

Detailed 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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • MA
    • Sao Luis, MA, Brazil, 65060-000
      • Hospital São Domingos

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Group; 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; Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein
ACTIVE_COMPARATOR: Control Group; 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; Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Sao Domingos

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Critical Illness; Dietary Proteins; Indirect Calorimetry
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HSaoDomingos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No