Clinical trial NCT04582630: Effects of Omega-3 Fatty Acids on Muscle Wasting
Official title: Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Wasting
Keywords: Critical Illness
Trauma
Fatty Acids
Anthropometry
Nutrition Disorders
Sarcopenia
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill trauma patients aged between 18 - 80 years of both sexes

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in rectus femoris muscle cross-sectional area
timeFrame: Baseline and 7 days
measure: Changes in mid-upper arm and calf circumferences
timeFrame: Baseline and 7 days
measure: Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness
timeFrame: Baseline and 7 days
measure: Changes in biochemical parameters related to muscle homeostasis, oxidative stress and inflammation
timeFrame: Baseline and 7 days
Secondary outcomes:
measure: Intensive care unit length of stay
timeFrame: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
measure: Hospital Length of Stay
timeFrame: Time of discharge from the ICU until hospital discharge, up to 1 year
measure: 28-day mortality
timeFrame: 28 day
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation
Study officials:
affiliation: Karadeniz Technical University
name: Ahmet Oguzhan Kucuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Melda Kangalgil, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Kıvanc Oncu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Serap Ozer Yaman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Sekine Turan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Süleyman Caner Karahan, MD
role: PRINCIPAL_INVESTIGATOR
References: