Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Sponsor

Hospital Sao Domingos (Other)

Overall Status

Terminated

CT.gov ID

NCT02731144

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis Septic Shock	Other: Peptamen intense Other: Novasource senior	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

10 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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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

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

Primary Outcome Measures

Physical function measured through the tool Physical Component Summary - PCS of Short Form 36 [Three months after randomization]

Secondary Outcome Measures

Hospital mortality [Up to 1 year]
Length of ICU stay [Up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Sao Domingos

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 7, 2016

Last Update Posted:

Mar 29, 2022

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by José Raimundo Araujo de Azevedo, MD, PhD, Hospital Sao Domingos

Loss of Physical Function

Additional relevant MeSH terms:

Shock, Septic

Shock

Study Results

No Results Posted as of Mar 29, 2022