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Optimized Caloric-proteic Nutrition in Critically Ill Patients

H

Hospital Sao Domingos

Status

Completed

Conditions

Critically Ill

Treatments

Other: Peptamen intense
Other: Novasource senior

Study type

Interventional

Funder types

Other

Identifiers

NCT03060668
HSaoDomingos

Details and patient eligibility

About

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).

Full 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.

Enrollment

138 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

138 participants in 2 patient groups

Study Group
Experimental group
Description:
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).
Treatment:
Other: Peptamen intense
Control Group
Active Comparator group
Description:
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.
Treatment:
Other: Novasource senior

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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