Clinical trial NCT04709198: Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients
Official title: The Association Between Nutritional Status and Muscle Wasting and Fraility in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Nutritional Disorder
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients aged between 45-80 years of both sexes

Brief summary: The risk of muscle wasting is high in the intensive care unit patients during the treatment process and this condition is associated with adverse clinical outcomes. The etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in muscle wasting treatment and prevention. The aim of this study is assesing the malnutrition and fraility, anthropometric measurements, and muscle mass by ultrasound at the first admission to the intensive care unit and to determine the nutritional factors affecting clinical outcomes. In addition, it is planned to determine the risk factors affecting the change of anthropometric measurements and muscle wasting in the first week during the intensive care unit.

Detailed description: A nutrition-focused physical examination is an integral component in the assessment of critically ill patients. Malnutrition, muscle wasting, and frailty are multidimensional clinical conditions in critically ill patients and are associated with adverse outcomes. Although malnutrition, muscle wasting and frailty are linked, the exact relation between them is unsure. As a result of evaluating these conditions together, it is planned to develop new treatment strategies and to improve the clinical results of patients by determining the relationship between medical nutrition therapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥45 years and ≤80 years, male or female
* Expected ICU stay of seven days or longer
* Written informed consent or requirements of local/national ethical committee

Exclusion Criteria:

* Pregnancy or breastfeeding
* Neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome)
* Terminal cancer
* Dialysis dependent chronic renal failure
* Intoxication
* Burn injury
* A cognitive impairment prior to the acute illness that is associated with admission to ICU that would impair capacity to follow verbal instructions
* Concurrent enrolment in a nutrition-related interventional study at the time of screening

Primary outcomes:
measure: Changes in muscle cross-sectional area
timeFrame: Baseline and 7 days
measure: Changes in anthropometric measurements
timeFrame: Baseline and 7 days
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
measure: Mortality rate
timeFrame: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Health Sciences
state: Eyalet/Yerleşke
Study officials:
affiliation: Karadeniz Technical University
name: Ahmet Oguzhan Kucuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Hulya Ulusoy, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Ayse Ozfer Ozcelik, Professor
role: PRINCIPAL_INVESTIGATOR
References: