NCT02731144

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 sepsis

Timeline
Completed

Started Jun 2016

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 29, 2022

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

March 31, 2016

Last Update Submit

March 14, 2022

Conditions

SepsisSeptic Shock

Keywords

Loss of Physical Function

Outcome Measures

Primary Outcomes (1)

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

    Three months after randomization

Secondary Outcomes (2)

  • Hospital mortality

    Up to 1 year

  • Length of ICU stay

    Up to 1 year

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Peptamen intenseOTHER
Study group
Novasource seniorOTHER
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Requirement for inspired oxygen content (FIO2) \> 0.60
  • High output bronchopleural fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • JOSE R AZEVEDO, PhD

    COORDINATOR ICU HOSPITAL SAO DOMINGOS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 7, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

February 1, 2018

Last Updated

March 29, 2022

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share