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Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Primary Purpose

Sepsis, Septic Shock

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Peptamen intense
Novasource senior
Sponsored by
Hospital Sao Domingos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Loss of Physical Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study group

    Control group

    Arm 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)

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Hospital mortality
    Length of ICU stay

    Full Information

    First Posted
    March 31, 2016
    Last Updated
    March 14, 2022
    Sponsor
    Hospital Sao Domingos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02731144
    Brief Title
    Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    The protocol was modified substantially and will be resubmitted to Clinical Trial
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Sao Domingos

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis, Septic Shock
    Keywords
    Loss of Physical Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Peptamen intense
    Intervention Type
    Other
    Intervention Name(s)
    Novasource senior
    Primary Outcome Measure Information:
    Title
    Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
    Time Frame
    Three months after randomization
    Secondary Outcome Measure Information:
    Title
    Hospital mortality
    Time Frame
    Up to 1 year
    Title
    Length of ICU stay
    Time Frame
    Up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JOSE R AZEVEDO, PhD
    Organizational Affiliation
    COORDINATOR ICU HOSPITAL SAO DOMINGOS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

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