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NCT02731144 Clinical Trial

Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02731144
Other study ID # CEP-HSD 33/2016
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date June 2016
Est. completion date February 2018

Study information
Verified date January 2018
Source Hospital Sao Domingos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date February 2018
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Peptamen intense

• Novasource senior

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Sao Domingos

Outcome
Type Measure Description Time frame Safety issue
Primary Physical function measured through the tool Physical Component Summary - PCS of Short Form 36 Three months after randomization
Secondary Hospital mortality Up to 1 year
Secondary Length of ICU stay Up to 1 year
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