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The risk of muscle wasting, and sarcopenia is high in the intensive care unit patients and associated with adverse clinical outcomes. The etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in treatment and prevention. The purpose of this study is to evaluate the effect of omega-3 fatty acids in the treatment and/or prevention of muscle wasting in critically ill trauma patients.
Low skeletal muscle mass and loss of lean tissue in critically illness have been associated with negative clinical outcomes. Critically ill patients may lose about 25% of their skeletal muscle mass within 7 days of admission to the intensive care unit. Besides increased protein catabolism, other factors inherent to the ICU environment contribute to muscle loss, including patient immobility and interruptions in nutrient delivery. This combination of factors is especially debilitating in patients with preexisting low muscle stores due to sarcopenia, chronic illness, or malnutrition. Although preservation of skeletal muscle mass is important for recovery in critically ill patients, the mechanism of muscle wasting is not unknown. Muscle wasting is a multifactorial process and it may be the consequence of several events, including oxidative stress, inflammatory conditions and muscle remodeling. Omega-3 fatty acids with their anti-inflammatory, antioxidant and anabolic effects can be a key factor for an effective treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 fatty acid | Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days. |
| |
| Control (standart) | Standart medical nutrition therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega 3 fatty acid | Dietary Supplement | Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in rectus femoris muscle cross-sectional area | Will be evaluated by ultrasound. | Baseline and 7 days |
| Changes in mid-upper arm and calf circumferences | Will be measured by tape measure. | Baseline and 7 days |
| Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness | Will be measured by caliper. | Baseline and 7 days |
| Changes in biochemical parameters related to muscle homeostasis, oxidative stress and inflammation | Biochemical parameters related to muscle wasting such as TNF-a, IL-6, TOS, P3NP | Baseline and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit length of stay | Time from study inclusion to intensive care unit discharge. | Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year |
| Hospital Length of Stay |
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Inclusion Criteria:
Age ≥18 years and ≤80 years, 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) Current cancer or chemotherapy End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission Burn injury History of transplantation Pretibial edema Uncontrolled hemorrhage Uncontrolled hyperlipidemia Acute pancreatitis Acute thromboembolic diseases Severe heart failure Septic shock Concurrent enrolment in a nutrition-related interventional study at the time of screening
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Critically ill trauma patients aged between 18 - 80 years of both sexes
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Oguzhan Kucuk, MD | Karadeniz Technical University | Principal Investigator |
| Melda Kangalgil, MSc | Karadeniz Technical University | Principal Investigator |
| Kıvanc Oncu, MD | Karadeniz Technical University | Principal Investigator |
| Serap Ozer Yaman, PhD | Karadeniz Technical University | Principal Investigator |
| Sekine Turan, MD | Karadeniz Technical University | Principal Investigator |
| Süleyman Caner Karahan, MD | Karadeniz Technical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation | Trabzon | 61100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D016638 | Critical Illness |
| D014947 | Wounds and Injuries |
| D009748 | Nutrition Disorders |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D015118 | Eicosapentaenoic Acid |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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TNF-a, IL-6, TOS, P3NP levels in muscle wasting
Time from study inclusion to hospital discharge.
| Time of discharge from the ICU until hospital discharge, up to 1 year |
| 28-day mortality | Mortality rate | 28 day |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D009750 | Nutritional and Metabolic Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D015777 | Eicosanoids |