Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

NCT04709198 | Completed

• 1 other identifier: 202057
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Nutritional Disorder

Outcome Measures

Primary Outcomes (2)

• Changes in muscle cross-sectional area

  Rectus femoris muscle cross-sectional area will be evaluated by ultrasound.

  Baseline and 7 days

• Changes in anthropometric measurements

  Triceps skinfold thickness will be measured by caliper.

  Baseline and 7 days

Secondary Outcomes (2)

• Duration of mechanical ventilation

  Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year

• Mortality rate

  Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients aged between 45-80 years of both sexes

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Health Sciences

Trabzon, Eyalet/Yerleşke, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness; Nutrition Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Ahmet Oguzhan Kucuk, MD

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Hulya Ulusoy, Professor

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Ayse Ozfer Ozcelik, Professor

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 14, 2021
• Study Start: October 20, 2020
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)