How COVID-19 Effects to Muscle Mass Change ın ICU?

Sarcopenia Clinical Trial

Official title:

USG evaluatıon of COVID-19 Related Muscle Mass Change in the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008562
• Other study ID #: 25-2021
• Status: Completed
• Start date: June 9, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: August 2021
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (+) 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 1, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being in the Intensive Care Unit

• Over the age of 18

• Diagnosed with COVID-19 pneumonia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Myopathy
• ICU Acquired Weakness
• Respiration Disorders
• Respiratory Tract Diseases
• Sarcopenia
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Other:
• COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT
there is no interventions to the patients.

Locations

Country	Name	City	State
Turkey	Gunes Comba Cebeci	Istanbul	Bayrampasa

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Effects of COVID-19 ARDS on ICU-AW development, nutrition.	The diet of the patients were standardized by the dietitian.	21 days