Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

Critical Illness Clinical Trial

Official title:

The Association Between Nutritional Status and Muscle Wasting and Fraility in Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709198
• Other study ID #: 202057
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: July 2022
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2021
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscular Atrophy
• Nutrition Disorders
• Nutritional Disorder

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University Faculty of Health Sciences	Trabzon	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in muscle cross-sectional area	Rectus femoris muscle cross-sectional area will be evaluated by ultrasound.	Baseline and 7 days
Primary	Changes in anthropometric measurements	Triceps skinfold thickness will be measured by caliper.	Baseline and 7 days
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation in survivors and non survivors	Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
Secondary	Mortality rate	ICU mortality	Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year