Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

March 14, 2022 updated by: José Raimundo Araujo de Azevedo, Hospital Sao Domingos

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
Time Frame: Three months after randomization
Three months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital mortality
Time Frame: Up to 1 year
Up to 1 year
Length of ICU stay
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Domingos

Investigators

  • Principal Investigator: JOSE R AZEVEDO, PhD, COORDINATOR ICU HOSPITAL SAO DOMINGOS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (ESTIMATE)

April 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP-HSD 33/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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