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Completed

NCT Number: NCT04709198

Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Nutrition Disorders Nutritional Disorder Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karadeniz Technical University Faculty of Health Sciences

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

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in muscle cross-sectional area

    Time frame: Baseline and 7 days

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

  2. Changes in anthropometric measurements

    Time frame: Baseline and 7 days

    Triceps skinfold thickness will be measured by caliper.

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: 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

  2. Mortality rate

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

    ICU mortality

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Jul 25, 2022

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.

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