Algarve
Faro, Portugal
NCT Number: NCT07268274
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Faro, Portugal
This single-center, longitudinal observational study enrolls critically ill adults who require invasive mechanical ventilation (IMV) for at least 48 hours and remain in the Intensive Care Unit (ICU) for more than 7 days. Participants are followed in-hospital for up to 42 days after ICU admission, unless discharged, deceased, or unable to continue accurate nutritional monitoring due to transition to oral feeding for nutritional purposes. The final assessment occurs on Day 90 after onset of critical illness, when functional status is evaluated using the Portuguese validated version of the EuroQol 5-Dimension Questionnaire (EQ-5D), administered either by telephone or in person depending on patient location.
Baseline characterization includes:
Metabolic assessment is performed using serial indirect calorimetry beginning on Day 7 of ICU stay and repeated one to three times per week up to Day 42 or until hospital discharge. Feasibility requires absence of air leaks in the respiratory system. For patients on invasive mechanical ventilation (IMV), measurements follow device requirements (fraction of inspired oxygen < 70% and positive end-expiratory pressure < 12 cmH₂O); for spontaneous ventilation, measurements are obtained in canopy mode at FiO₂ 21%. Weekly metabolic values are calculated as the average of available measurements.
Protein intake is recorded according to routine clinical practice and quantified weekly after Day 7, expressed in grams (g) per kilogram of adjusted body weight per day (g/kg/day). Protein delivered as amino acids is converted to grams of protein using a standard factor (100 g hydrolyzed protein = 83 g amino acids). Total caloric intake is also quantified weekly, including enteral and parenteral nutrition as well as non-nutritional caloric sources such as glucose-containing solutions and propofol.
Inflammatory status is assessed weekly using C-reactive protein (CRP) and procalcitonin measurements.
Patients are monitored according to routine clinical practice, and 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). Outcomes include:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From Day 7 of Intensive Care Unit stay through Day 42 or until Intensive Care Unit, whichever occurs first.
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.
Time frame: At Intensive Care Unit (ICU) discharge; at Day 28 after ICU admission; at hospital discharge; at Day 90 after ICU admission.
Mortality at multiple time points. Values: Alive/Dead.
Time frame: From endotracheal intubation to extubation or transition to intermittent ventilation via tracheostomy, up to Day 42 of ICU stay.
Number of days the patient requires invasive mechanical ventilation, from the time of endotracheal intubation until extubation or transition to intermittent ventilation via tracheostomy.
Time frame: From Day 7 of Intensive Care Unit stay through Day 42 or until Intensive Care Unit discharge, whichever occurs first
Daily protein intake will be recorded based on routine clinical practice. Values will be reported in grams per kilogram of body weight per day (g/kg/day). Weekly averages will be calculated to characterize protein provision during prolonged critical illness.
Time frame: From tracheostomy insertion through decannulation, up to 90 days.
Number of days from tracheostomy insertion to decannulation, if performed.
Time frame: From Intensive Care Unit admission through Day 30
Number of infections diagnosed within 30 days of Intensive Care Unit admission. Defined as the number of infectious agentes, not deemed to be colonization, in biological samples performed in accordance with local standard practice
Time frame: From Intensive Care Unit admission through Day 90.
Number of days the patient is alive and not in the Intensive Care Unit, calculated from Intensive Care Unit admission through Day 90.
Time frame: From hospital admission through Day 90.
Number of days the patient is alive and not in the hospital, calculated from hospital admission through Day 90.
Time frame: At Day 42 after Intensive Care Unit admission
Discharge destination among survivors. Values: Home/Institution (for example, rehabilitation facility).
Time frame: At Day 90 after Intensive Care Unit admission
Patient functional status measured using the EQ-5D scale among survivors at Day 90.
Universidade do Algarve
Other
Metabolism and the Impact of Protein Intake in Chronic Critically Ill Adult Patients: Protocol for a Unicentric Prospective Cohort Study (MetaChronic Study)
Acronym: MetaChronic
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04017299
Adult ICU Patients, Anxiety Disorders
Montpellier, France
View Trial DetailsNCT03641911
Acute Pain, Adult ICU Patients
Bangkok Noi, Bangkok, Thailand
View Trial DetailsNCT03164525
Adult ICU Patients
Bangkok Noi, Bangkok, Thailand
View Trial DetailsNCT06489431
Erectile Dysfunction, Genital Diseases
Mountain View, California, United States
View Trial Details