Optimized Caloric-proteic Nutrition in Critically Ill Patients

NCT03060668 | Completed DMC

• 1 other identifier: HSaoDomingos
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).

Conditions

Critically Ill

Keywords

Critical Illness; Indirect Calorimetry; Dietary Proteins

Outcome Measures

Primary Outcomes (1)

• PCS of SF-36

  Physical component summary of Short Form 36

  6 months after randomization

Secondary Outcomes (3)

• Handgrip strength

  7th, 14th after admission and up to 30 days

• ICU mortality

  Up to 30 days

• Hospital mortality

  Up to 6 months

Study Arms (2)

Study Group

EXPERIMENTAL

Caloric needs will be determined by indirect calorimetry. Patients in this group will receive 2.0 to 2.2 grams/kg/day of protein. Nutritional therapy will be initiated in the first 24 hours after admission. Nutritional formula will be Peptamen Intense (1.0 kcal/ml, 93 g/L protein (Nestle Health Care).

Other: Peptamen intense

Control Group

ACTIVE COMPARATOR

Patients in this group will receive 25 Kcal/kg/day and 1.4 to 1.5 grams/kg/day of protein. Nutritional formula in this group will be Novasource senior (Nestle Health Care). Nutritional therapy will be initiated in the first 24 hours after admission.

Other: Novasource senior

Interventions

Peptamen intense OTHER

Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein

Study Group

Novasource senior OTHER

Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill patients Mechanically ventilated Expected length in the ICU \> 3 days

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-000, Brazil

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JOSE R AZEVEDO, PhD

  Hospital Sao Domingos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 23, 2017
• Study Start: June 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 16, 2022

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)