SARS-CoV-2 Acute Respiratory DiseaseNCT05008562
How COVID-19 Effects to Muscle Mass Change ın ICU?
An observational study of SARS-CoV-2 Acute Respiratory Disease and Sarcopenia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Critical illness myopathy and neuropathy are associated with prolonged mechanical ventilation, resulting in increased morbidity and mortality in intensive care units, .the investigators aimed to determine the decrease in muscle mass and risk factors that are important causes for the development of myopathy in COVID-19… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease, Sarcopenia, ICU Acquired Weakness
- What is being tested?
- COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jun 2021to 1 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Being in the Intensive Care Unit * Over the age of 18 * Diagnosed with COVID-19 pneumonia
Who may be able to join
- Being in the Intensive Care Unit
- Over the age of 18
- Diagnosed with COVID-19 pneumonia
Who cannot join
- Under the age of 18
- Pregnancy
- Having a cardiac pacemaker
- Amputated lower limbs Having severe venous insufficiency or major injuries to their lower extremities
- Having neuromuscular disease
- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: USG evaluatıon of COVID-19 Related Muscle Mass Change in the ICU
Critical illness myopathy and neuropathy are associated with prolonged mechanical ventilation, resulting in increased morbidity and mortality in intensive care units, .the investigators aimed to determine the decrease in muscle mass and risk factors that are important causes for the development of myopathy in COVID-19 (+) patients followed in intensive care unit. The study will also evaluate the relationships of patients withthe investigators intensive care-associated muscle weakness (ICU-AW) with other intensive care patient weight scores (SOFA, APACHE II, q SOFA).
Sensitivity of anthropometric measurements and ultrasonographic measurements will be compared in the evaluation of sarcopenia. The length of hospital stay, mechanical ventilation time, patient outcomes (mortality/morbidity) information of patients with COVID-19 pneumonia followed in the intensive care unit will be evaluated.
Read the detailed description
Sarcopenia (muscle weakness) is one of the geriatric syndromes that increases in frequency with age and is characterized by a decrease in muscle mass, strength and performance. Sarcopenia that occurs with aging is called primary sarcopenia, but sarcopenia can also occur due to secondary causes such as malnutrition, chronic diseases and immobility. One of the most important risk factors is advanced age. The prevalence of sarcopenia, which has been reported between 5% and 13% in a decade, can reach up to 50% over the age of 80. Sarcopenia is an important health problem that can cause loss of mobility, risk of functional dependence, risk of falling, increase in hospital stay, and consequently increase in morbidity and mortality, especially in elderly patients.
In order to be able to say sarcopenia, the investigators need to show that there is a decrease in muscle mass and, in addition, muscle strength and/or performance. Bio-electrical impedance analysis, anthropometric measurements or radiological measurements can be used among the most commonly used methods when evaluating muscle mass. However, there is no single gold standard measurement. Cross-sectional muscle area measurements, lean mass measurements and calf circumference measurements are the most commonly used muscle mass determination methods.
Ultrasonographic measurement of the rectus femoris muscle is a muscle mass measurement technique that has been used frequently recently. The most important measurement method used as a standard for muscle strength measurement is hand grip strength. The hand grip strength values reported for weakness acquired in the intensive care unit are at lower limits. <11 kg in male patients and <7 kg in female patients are considered significant limits for ICU-AW (intensive care unit-aquire weakness). However, there are some difficulties in evaluating muscle strength in intensive care patients. Most importantly, most of the patients are bedridden, immobile, receiving ventilation support, unable to cooperate, and who will not be conscious because they are under anesthesia. Apart from this, there are some measurement methods by sending magnetic or electrophysiological stimuli to the peripheral nerves in intensive care patients for muscle strength measurement, but they are mostly applied for clinical studies for now, due to the fact that they are invasive measurement methods and there are not enough equipped centers to apply them. In conclusion, sufficient number of studies examining this issue are required to reach a consensus on how to diagnose sarcopenia in intensive care patients.
In today's conditions, patients with a diagnosis of COVID-19 pneumonia are followed in the majority of intensive care units. In the study, patients with a diagnosis of COVID-19 followed in the intensive care unit will be evaluated. It is aimed to monitor, detect and investigate the factors affecting the muscle weakness of the disease, which the investigatorshave just met during the pandemic the investigators are in, and which causes different systemic involvement. There is no previous study on this subject in the literature.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease, Sarcopenia, ICU Acquired Weakness, Critical Illness Myopathy
- Being tested
- COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT
- Keywords
- Sarcopenia, ICU Acquired Weakness, SARS-CoV-2 Acute Respiratory Disease,
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNITOther
there is no interventions to the patients.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT | Patients over the age of 18 who are hospitalized in our intensive care unit with a diagnosis of COVID-19 will be included in the study.
The day the patients are admitted to the intensive care unit will be considered the 1st day of the study. SOFA, qSOFA, APACHE II, CRP, procalcitonin values will be recorded on the first day. On the first day of our patients, rectus femoris muscle thickness measurement will be done ultrasonographically (bilateral). In addition, bilateral thigh circumference will be measured anthropometrically (with a tape measure). It is planned to evaluate the muscle strength of the patients according to the MRC (Medical Research Council) scoring.
In addition to these measurements, the creatine kinase values in the routine clinical follow-up of the patients, the differences between the fluid intake and output values, inotropic supplements used in their treatment, diuretic needs, and neuromuscular blocker use will also be noted. Receives: Other: COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of COVID-19 ARDS on ICU-AW development, anthropometric measurement,
The measurements of the patients were recorded as anthropometric ( thigh circumference) on the 1st, 7th, 14th and 21st days. Thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension.
Measured: Change from baseline in thigh circumference at 21 days
Effects of COVID-19 ARDS on ICU-AW development, ultrasonographic measurement
Using an ultrasound imaging device, the thickness of rectus femoris muscles (cm^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe.
Measured: Change from baseline in thigh circumference at 21 days
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.
Measured: Change from baseline in thigh circumference at 21 days
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients.
Measured: Change from baseline at 21 days
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.
Measured: Change from baseline at 21 days
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients.
Measured: only first day
Effects of COVID-19 ARDS on ICU-AW development, nutrition.
The diet of the patients were standardized by the dietitian.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start9 Jun 2021
- Primary completion9 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUNES COMBA CEBECI, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008562
- Sponsor's protocol ID
- 25-2021
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USG evaluatıon of COVID-19 Related Muscle Mass Change in the ICU
- ClinicalTrials.gov ID
- NCT05008562
- Acronym / sponsor ID
- 25-2021
- Conditions
- SARS-CoV-2 Acute Respiratory Disease, Sarcopenia, ICU Acquired Weakness, Critical Illness Myopathy
- Keywords
- Sarcopenia, ICU Acquired Weakness, SARS-CoV-2 Acute Respiratory Disease,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Aug 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.
Critical illness myopathy and neuropathy are associated with prolonged mechanical ventilation, resulting in increased morbidity and mortality in intensive care units, .the investigators aimed to determine the decrease in muscle mass and risk factors that are important causes for the development of myopathy in COVID-19 (+) patients followed in intensive care unit. The study will also evaluate the relationships of patients withthe investigators intensive care-associated muscle weakness (ICU-AW) with other intensive care patient weight scores (SOFA, APACHE II, q SOFA).
Sensitivity of anthropometric measurements and ultrasonographic measurements will be compared in the evaluation of sarcopenia. The length of hospital stay, mechanical ventilation time, patient outcomes (mortality/morbidity) information of patients with COVID-19 pneumonia followed in the intensive care unit will be evaluated.
Detailed description
Sarcopenia (muscle weakness) is one of the geriatric syndromes that increases in frequency with age and is characterized by a decrease in muscle mass, strength and performance. Sarcopenia that occurs with aging is called primary sarcopenia, but sarcopenia can also occur due to secondary causes such as malnutrition, chronic diseases and immobility. One of the most important risk factors is advanced age. The prevalence of sarcopenia, which has been reported between 5% and 13% in a decade, can reach up to 50% over the age of 80. Sarcopenia is an important health problem that can cause loss of mobility, risk of functional dependence, risk of falling, increase in hospital stay, and consequently increase in morbidity and mortality, especially in elderly patients.
In order to be able to say sarcopenia, the investigators need to show that there is a decrease in muscle mass and, in addition, muscle strength and/or performance. Bio-electrical impedance analysis, anthropometric measurements or radiological measurements can be used among the most commonly used methods when evaluating muscle mass. However, there is no single gold standard measurement. Cross-sectional muscle area measurements, lean mass measurements and calf circumference measurements are the most commonly used muscle mass determination methods.
Ultrasonographic measurement of the rectus femoris muscle is a muscle mass measurement technique that has been used frequently recently. The most important measurement method used as a standard for muscle strength measurement is hand grip strength. The hand grip strength values reported for weakness acquired in the intensive care unit are at lower limits. <11 kg in male patients and <7 kg in female patients are considered significant limits for ICU-AW (intensive care unit-aquire weakness). However, there are some difficulties in evaluating muscle strength in intensive care patients. Most importantly, most of the patients are bedridden, immobile, receiving ventilation support, unable to cooperate, and who will not be conscious because they are under anesthesia. Apart from this, there are some measurement methods by sending magnetic or electrophysiological stimuli to the peripheral nerves in intensive care patients for muscle strength measurement, but they are mostly applied for clinical studies for now, due to the fact that they are invasive measurement methods and there are not enough equipped centers to apply them. In conclusion, sufficient number of studies examining this issue are required to reach a consensus on how to diagnose sarcopenia in intensive care patients.
In today's conditions, patients with a diagnosis of COVID-19 pneumonia are followed in the majority of intensive care units. In the study, patients with a diagnosis of COVID-19 followed in the intensive care unit will be evaluated. It is aimed to monitor, detect and investigate the factors affecting the muscle weakness of the disease, which the investigatorshave just met during the pandemic the investigators are in, and which causes different systemic involvement. There is no previous study on this subject in the literature.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT | – | Other: COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNITPatients over the age of 18 who are hospitalized in our intensive care unit with a diagnosis of COVID-19 will be included in the study. The day the patients are admitted to the intensive care unit will be considered the 1st day of the study. SOFA, qSOFA, APACHE II, CRP, procalcitonin values will be recorded on the first day. On the first day of our patients, rectus femoris muscle thickness measurement will be done ultrasonographically (bilateral). In addition, bilateral thigh circumference will be measured anthropometrically (with a tape measure). It is planned to evaluate the muscle strength of the patients according to the MRC (Medical Research Council) scoring. In addition to these measurements, the creatine kinase values in the routine clinical follow-up of the patients, the differences between the fluid intake and output values, inotropic supplements used in their treatment, diuretic needs, and neuromuscular blocker use will also be noted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Being in the Intensive Care Unit * Over the age of 18 * Diagnosed with COVID-19 pneumonia
Key inclusion criteria (3 listed)
- Being in the Intensive Care Unit
Key exclusion criteria (6 listed)
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNITthere is no interventions to the patients. | Other | COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT |
Primary outcome
Effects of COVID-19 ARDS on ICU-AW development, anthropometric measurement,
Time frame: Change from baseline in thigh circumference at 21 days
The measurements of the patients were recorded as anthropometric ( thigh circumference) on the 1st, 7th, 14th and 21st days. Thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension.
Effects of COVID-19 ARDS on ICU-AW development, ultrasonographic measurement
Time frame: Change from baseline in thigh circumference at 21 days
Using an ultrasound imaging device, the thickness of rectus femoris muscles (cm^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe.
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
Time frame: Change from baseline in thigh circumference at 21 days
The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
Time frame: Change from baseline at 21 days
On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients.
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
Time frame: Change from baseline at 21 days
On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.
Effects of COVID-19 ARDS on ICU-AW development, scoring systems.
Time frame: only first day
On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients.
Effects of COVID-19 ARDS on ICU-AW development, nutrition.
Time frame: 21 days
The diet of the patients were standardized by the dietitian.
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 23 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV-2 Acute Respiratory Disease and Sarcopenia, run by Ondokuz Mayıs 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 6 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 23 Dec 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?
Effects of COVID-19 ARDS on ICU-AW development, anthropometric measurement, (time frame: Change from baseline in thigh circumference at 21 days). The study lists 7 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 23 Dec 2022.