Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

Sponsor
Karadeniz Technical University (Other)
Overall Status
Completed
CT.gov ID
NCT04709198
Collaborator
(none)
44
1
20
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    44 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Association Between Nutritional Status and Muscle Wasting and Fraility in Intensive Care Patients
    Actual Study Start Date :
    Oct 20, 2020
    Actual Primary Completion Date :
    Jun 20, 2021
    Actual Study Completion Date :
    Jun 20, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Changes in muscle cross-sectional area [Baseline and 7 days]

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

    2. Changes in anthropometric measurements [Baseline and 7 days]

      Triceps skinfold thickness will be measured by caliper.

    Secondary Outcome Measures

    1. 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

    2. Mortality rate [Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year]

      ICU mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karadeniz Technical University Faculty of Health Sciences Trabzon Eyalet/Yerleşke Turkey 61080

    Sponsors and Collaborators

    • Karadeniz Technical University

    Investigators

    • Principal Investigator: Ahmet Oguzhan Kucuk, MD, Karadeniz Technical University
    • Principal Investigator: Hulya Ulusoy, Professor, Karadeniz Technical University
    • Principal Investigator: Ayse Ozfer Ozcelik, Professor, Ankara University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melda Kangalgil, Research Assistant, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT04709198
    Other Study ID Numbers:
    • 202057
    First Posted:
    Jan 14, 2021
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 25, 2022