Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Phase 4

Terminated

• Conditions: Sepsis; Septic Shock
• Interventions: Other: Novasource senior; Other: Peptamen intense

• Registration Number: NCT02731144
• Lead Sponsor: Hospital Sao Domingos

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-07
• Study Start: 2016-06
• Primary Completion: 2017-05
• Status Verified: 2018-01
• Study Completion: 2018-02
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

• Pregnancy
• Requirement for inspired oxygen content (FIO2) > 0.60
• High output bronchopleural fistula

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	Novasource senior	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.
Study group	Peptamen intense	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)

Primary Outcome Measures

Name	Time	Method
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36	Three months after randomization

Secondary Outcome Measures

Name	Time	Method
Hospital mortality	Up to 1 year
Length of ICU stay	Up to 1 year