The Impact of Optimized Caloric-proteic Nutrition on Clinical Outcome and Physical Component Summary (PCS) of Quality of Life in Septic and Septic Shock Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Hospital Sao Domingos
- Enrollment
- 10
- Primary Endpoint
- Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Study group
Individualization of caloric administration with indirect calorimetry and 2.0 to 2.2 g/kg/day of protein. Early initiation of nutritional support (24 hours of admission)
Intervention: Peptamen intense (Other)
Control group
Nutritional support initiated in the first 24 hours of admission. Protein and caloric goals calculated as 25 Kcal/kg/day and 1.4 to 1.5 g/kg/day of protein.
Intervention: Novasource senior (Other)
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(Up to 1 year)
- Length of ICU stay(Up to 1 year)
Investigators
José Raimundo Araujo de Azevedo
MD, PhD
Hospital Sao Domingos