Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Phase 4TerminatedNCT02731144

Hospital Sao Domingos10 enrolled

Overview

In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sepsis Septic Shock

Interventions

Peptamen intenseOTHER

Novasource seniorOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock * Mechanically ventilated * Expected length of stay in ICU ≥ 4 days * Written informed consent obtained from authorized surrogates Exclusion Criteria: * Pregnancy * Requirement for inspired oxygen content (FIO2) \> 0.60 * High output bronchopleural fistula

Outcomes

Primary Outcomes

Physical function measured through the tool Physical Component Summary - PCS of Short Form 36

Time frame: Three months after randomization

Secondary Outcomes

Hospital mortality

Time frame: Up to 1 year

Length of ICU stay

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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