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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04582630
Other study ID # Karadeniz TU
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 20, 2020
Est. completion date December 20, 2021

Study information

Verified date October 2020
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date December 20, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
omega 3 fatty acid
Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.

Locations

Country Name City State
Turkey Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in rectus femoris muscle cross-sectional area Will be evaluated by ultrasound. Baseline and 7 days
Primary Changes in mid-upper arm and calf circumferences Will be measured by tape measure. Baseline and 7 days
Primary Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness Will be measured by caliper. Baseline and 7 days
Primary 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
Secondary 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
Secondary Hospital Length of Stay Time from study inclusion to hospital discharge. Time of discharge from the ICU until hospital discharge, up to 1 year
Secondary 28-day mortality Mortality rate 28 day
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