How COVID-19 Effects to Muscle Mass Change ın ICU?
USG evaluatıon of COVID-19 Related Muscle Mass Change in the ICU
1 other identifier
observational
25
1 country
1
Brief 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 (+) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2021
CompletedFirst Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedDecember 23, 2022
August 1, 2021
Same day
June 11, 2021
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
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.
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.
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.
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.
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.
only first day
Effects of COVID-19 ARDS on ICU-AW development, nutrition.
The diet of the patients were standardized by the dietitian.
21 days
Study Arms (1)
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.
Interventions
there is no interventions to the patients.
Eligibility Criteria
Being in the Intensive Care Unit * Over the age of 18 * Diagnosed with COVID-19 pneumonia
You may qualify if:
- Being in the Intensive Care Unit
- Over the age of 18
- Diagnosed with COVID-19 pneumonia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gunes Comba Cebeci
Istanbul, Bayrampasa, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- specialist
Study Record Dates
First Submitted
June 11, 2021
First Posted
August 17, 2021
Study Start
June 9, 2021
Primary Completion
June 9, 2021
Study Completion
September 1, 2021
Last Updated
December 23, 2022
Record last verified: 2021-08