Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Hospital Sao Domingos

Status and phase: Terminated; Phase 4

Conditions: Septic Shock; Sepsis

Treatments: Other: Novasource senior; Other: Peptamen intense

Study type: Interventional

Funder types: Other

Identifiers

NCT02731144

CEP-HSD 33/2016

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Study group

Experimental group

Description:

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)

Treatment:

Other: Peptamen intense

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Novasource senior