Critical IllnessNCT04709198
Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients
An observational study of Critical Illness and Nutritional Disorder, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Critical Illness, Nutritional Disorder
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2020to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Adult, Older adult
Study population: Critically ill patients aged between 45-80 years of both sexes
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Health Sciences
Trabzon, Eyalet/Yerleşke, 61080
About this study
Official title: The Association Between Nutritional Status and 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.
Read the 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.
- Conditions
- Critical Illness, Nutritional Disorder
- Medical subject headings
- Critical Illness, Nutrition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle cross-sectional area
Rectus femoris muscle cross-sectional area will be evaluated by ultrasound.
Measured: Baseline and 7 days
Changes in anthropometric measurements
Triceps skinfold thickness will be measured by caliper.
Measured: Baseline and 7 days
Secondary outcomes (2)
Duration of mechanical ventilation
Duration of mechanical ventilation in survivors and non survivors
Measured: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
Mortality rate
ICU mortality
Measured: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start20 Oct 2020
- Primary completion20 Jun 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melda Kangalgil, Karadeniz Technical University
- Investigators
- Ahmet Oguzhan Kucuk, MD, Principal investigator, Karadeniz Technical UniversityHulya Ulusoy, Professor, Principal investigator, Karadeniz Technical UniversityAyse Ozfer Ozcelik, Professor, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709198
- Sponsor's protocol ID
- 202057
- Status last verified
- Jul 2022
- First submitted
- 4 Jan 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Nutritional Status and Muscle Wasting and Fraility in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04709198
- Acronym / sponsor ID
- 202057
- Conditions
- Critical Illness, Nutritional Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients aged between 45-80 years of both sexes
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in muscle cross-sectional area
Time frame: Baseline and 7 days
Rectus femoris muscle cross-sectional area will be evaluated by ultrasound.
Changes in anthropometric measurements
Time frame: Baseline and 7 days
Triceps skinfold thickness will be measured by caliper.
2 secondary outcomes
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
Mortality rate
Time frame: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Oguzhan Kucuk, MD principal investigator
Karadeniz Technical University
Hulya Ulusoy, Professor principal investigator
Karadeniz Technical University
Ayse Ozfer Ozcelik, Professor principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Nutritional Disorder, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle cross-sectional area (time frame: Baseline and 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.