Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

Completed

• Conditions: Nutritional Disorder; Critical Illness

• Registration Number: NCT04709198
• Lead Sponsor: Karadeniz Technical University

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.

Study Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2021-06-20
• Study Completion: 2022-06-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in muscle cross-sectional area	Baseline and 7 days	Rectus femoris muscle cross-sectional area will be evaluated by ultrasound.
Changes in anthropometric measurements	Baseline and 7 days	Triceps skinfold thickness will be measured by caliper.

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year	Duration of mechanical ventilation in survivors and non survivors
Mortality rate	Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year	ICU mortality

Trial Locations

Locations (1)

Karadeniz Technical University Faculty of Health Sciences; 🇹🇷 Trabzon, Eyalet/Yerleşke, Turkey