Optimized Caloric-proteic Nutrition in Critically Ill Patients
NCT ID: NCT03060668
Last Updated: 2022-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2016-06-30
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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).
Peptamen intense
Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein
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.
Novasource senior
Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein
Interventions
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Peptamen intense
Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein
Novasource senior
Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital Sao Domingos
OTHER
Responsible Party
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José Raimundo Araujo de Azevedo
PhD
Principal Investigators
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JOSE R AZEVEDO, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sao Domingos
Locations
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Hospital Sao Domingos
São Luís, Maranhão, Brazil
Countries
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Other Identifiers
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HSaoDomingos
Identifier Type: -
Identifier Source: org_study_id
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