Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Peptamen intense

Intervention Type 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.

Group Type ACTIVE_COMPARATOR

Novasource senior

Intervention Type OTHER

Interventions

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Peptamen intense

Intervention Type OTHER

Novasource senior

Intervention Type OTHER

Eligibility Criteria

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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