Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02731144

Enrollment

Registered

2016-04-07

Start date

2016-06-30

Completion date

2018-02-28

Last updated

2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

Loss of Physical Function

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).

Interventions

OTHERPeptamen intense

OTHERNovasource senior

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Hospital mortality	Up to 1 year
Length of ICU stay	Up to 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026