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Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

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ClinicalTrials.gov Identifier: NCT02731144
Recruitment Status : Suspended (The protocol was modified substantially and will be resubmitted to Clinical Trial)
First Posted : April 7, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Other: Peptamen intense Other: Novasource senior Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Other: Peptamen intense
Active Comparator: 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.
 Other: Novasource senior


Outcome Measures
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Primary Outcome Measures :
  1. Physical function measured through the tool Physical Component Summary - PCS of Short Form 36 [ Time Frame: Three months after randomization ]

Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: Up to 1 year ]
  2. Length of ICU stay [ Time Frame: Up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731144


Sponsors and Collaborators
Hospital Sao Domingos
Investigators
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Principal Investigator: JOSE R AZEVEDO, PhD COORDINATOR ICU HOSPITAL SAO DOMINGOS
More Information
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Responsible Party: José Raimundo Araujo de Azevedo, MD, PhD, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT02731144    
Other Study ID Numbers: CEP-HSD 33/2016
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
Loss of Physical Function
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
 Infections
Systemic Inflammatory Response Syndrome
Inflammation