Metabolic Trajectories and Protein Intake in Long-Stay Ventilated Intensive Care Unit (ICU) Patients

NCT07268274 | Active Not Recruiting

• 1 other identifier: UAlg_a81228_SCastro
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Survival of critically ill patients has improved, resulting in a growing population of chronically critically ill (CCI) individuals with prolonged organ dysfunction, mechanical ventilation, and high morbidity. While nutritional guidelines during the acute phase are well established, evidence on protein intake in CCI patients is limited. Inflammation may influence metabolic responses and clinical outcomes, highlighting the need for prospective studies. The MetaChronic Study is a single-center, prospective cohort designed to describe metabolic trajectories and evaluate the effect of protein intake on outcomes in critically ill adults. Resting energy expenditure will be measured by serial indirect calorimetry, protein and caloric intake will be recorded weekly, and inflammation will be assessed using C-reactive protein (CRP) and procalcitonin. Secondary objectives include subgroup analyses, assessment of protein delivery routes, and exploration of interactions between protein intake, caloric intake, and inflammation.

Conditions

Adult ICU Patients

Keywords

Metabolism; Chronic critically ill adult patients; Nutrition; inflammation

Outcome Measures

Primary Outcomes (1)

• Resting Energy Expenditure (REE)

  Resting energy expenditure will be measured by indirect calorimetry using a calorimeter, which calculates energy expenditure in kilocalories (Kcal) per day from oxygen consumption and carbon dioxide production. Serial measurements will characterize metabolic trajectories during prolonged critical illness.

  From Day 7 of Intensive Care Unit stay through Day 42 or until Intensive Care Unit, whichever occurs first.

Secondary Outcomes (9)

• Mortality

  At Intensive Care Unit (ICU) discharge; at Day 28 after ICU admission; at hospital discharge; at Day 90 after ICU admission.

• Duration of Invasive Mechanical Ventilation

  From endotracheal intubation to extubation or transition to intermittent ventilation via tracheostomy, up to Day 42 of ICU stay.

• Protein Intake

  From Day 7 of Intensive Care Unit stay through Day 42 or until Intensive Care Unit discharge, whichever occurs first

• Tracheostomy Duration

  From tracheostomy insertion through decannulation, up to 90 days.

• Number of Infections

  From Intensive Care Unit admission through Day 30

Study Arms (1)

Long-Stay critically ill patients

This cohort includes critically ill adults who remain in the Intensive Care Unit (ICU) for more than 7 days and receive invasive mechanical ventilation for at least 48 hours. Patients are monitored according to routine clinical practice. Resting energy expenditure is assessed by serial indirect calorimetry, and inflammatory status is evaluated weekly using C-reactive protein (CRP) and procalcitonin. Daily protein intake is recorded and expressed in grams per kilogram of body weight per day. Comparative analyses will evaluate outcomes according to protein intake achieved during the second week of ICU stay (\>1.3 vs. ≤1.3 g/kg/day).

Eligibility Criteria

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

Study Population

The study will include adult critically ill patients admitted to intensive care who meet the eligibility criteria described.

You may qualify if:

• Adult critically ill patients admitted to Intensive Care Unit \> 7 days
• Invasive mechanical ventilation (IMV) \> 48 hours

You may not qualify if:

• Active oncological disease
• Neuromuscular diseases
• Confirmed or predicted Glasgow Coma Score \< 10 at 14 days in Intensive Care Unit
• Pregnant women

Sponsors & Collaborators

• Universidade do Algarve: lead

Study Sites (1)

Algarve

Faro, Portugal

Location

Related Publications (1)

• Moonen HPFX, Beckers KJH, van Zanten ARH. Energy expenditure and indirect calorimetry in critical illness and convalescence: current evidence and practical considerations. J Intensive Care. 2021 Jan 12;9(1):8. doi: 10.1186/s40560-021-00524-0.

  PMID: 33436084 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Binnie

  Universidade do Algarve

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Intensive Care Physician

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 5, 2025
• Study Start: March 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: December 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months after publication and ending 2 years after the publication of results
• Access Criteria: De-identified individual participant data and supporting documents (protocol, analysis plan, CRFs) will be made available as supplementary material to the publication and can also be shared with qualified researchers upon reasonable request. Access requires submission of a research proposal and signing a data use agreement to ensure confidentiality and compliance with ethical regulations.

Locations

PT (1)