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Optimized Caloric-proteic Nutrition in Critically Ill Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03060668
Enrollment
138
Registered
2017-02-23
Start date
2016-06-30
Completion date
2018-12-31
Last updated
2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill

Keywords

Critical Illness, Indirect Calorimetry, Dietary Proteins

Brief 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).

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.

Interventions

Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein

Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein

Sponsors

Hospital Sao Domingos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PCS of SF-366 months after randomizationPhysical component summary of Short Form 36

Secondary

MeasureTime frameDescription
Handgrip strength7th, 14th after admission and up to 30 daysMeasured using a calibrated dynamometer
ICU mortalityUp to 30 daysICU outcome
Hospital mortalityUp to 6 monthsHospital outcome

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026