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Clinical Trials/NCT02731144
NCT02731144
Terminated
Phase 4

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

Hospital Sao Domingos0 sites10 target enrollmentJune 2016
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ConditionsSepsisSeptic Shock

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Sepsis
Sponsor
Hospital Sao Domingos
Enrollment
10
Primary Endpoint
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
Status
Terminated
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
February 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Raimundo Araujo de Azevedo

MD, PhD

Hospital Sao Domingos

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

Outcomes

Primary Outcomes

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

Time Frame: Three months after randomization

Secondary Outcomes

  • Hospital mortality(Up to 1 year)
  • Length of ICU stay(Up to 1 year)

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