Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

NCT ID: NCT04709198

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-06-20

Brief Summary

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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

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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.

Conditions

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Critical Illness Nutritional Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Melda Kangalgil

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet Oguzhan Kucuk, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Hulya Ulusoy, Professor

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Ayse Ozfer Ozcelik, Professor

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Karadeniz Technical University Faculty of Health Sciences

Trabzon, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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202057

Identifier Type: -

Identifier Source: org_study_id

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