Effect of EPA and HMB on Strength in ICU Patients

Completed · Not applicable

Conditions studied: Muscle Weakness

In brief

The investigators will determine if administration of HMB (hydroxymethylbutyrate) or EPA (eicosapentaenoic acid) will increase diaphragm and limb muscle strength for patients on breathing machines in an intensive care unit. The investigators will first measure the strength of the diaphragm and a limb muscle (the quadriceps)using magnetic stimulators to activate these muscles. Muscle size will be measured by using an ultrasound to measure diaphragm thickness and quadriceps thickness. The investigators will also perform a vastus lateralis muscle biopsy. Patients will then be randomized to receive either placebo (saline 30 ml every 12 hours via the GI tract, EPA (1000 mg given every 12 hours via the GI tract), HMB (1500 mg given every 12 hours via the GI tract), or the combination of EPA (1000 mg given every 12 hours via the GI tract) and HMB (1500 mg given every 12 hours via the GI tract). Drugs will be given for 10 days; at the end of this time (on day 11), strength measurements, ultrasound muscle size measurements, and the vastus lateralis biopsy will be repeated. On day 21 an additional followup set of diaphragm and quadriceps strength and size measurements will be made (the biopsy will not be repeated for this last set of measurements). Patients will be followed clinically and patient outcomes (mortality, duration of mechanical ventilation after study entry) will be recorded.

Key facts

Study ID

NCT01270516

Run by

Gerald Supinski

People needed

73

Starts

2014-01-01

Expected to finish

2020-01-20

Last updated by the study team

2021-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients requiring mechanical ventilation for more than 24 hours in one of the University of Kentucky adult ICU's

You may not qualify if…

• The physician caring for the patient determines that the patient is too unstable to tolerate these measurements,
• If the patient requires high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine),
• If the patient requires more than 80% FiO2 or more than 15 cm H2O of PEEP,
• If the patient has a cardiac pacemaker or implanted defibrillator,
• If the patient has received neuromuscular blocking agents within the 48 hours preceding testing or has a known preexisting muscular disease,
• If the patient has a recent history of variceal bleeding,
• If the patient is excessively sedated or mentally obtunded as judged by an inability to follow verbal commands.
• We will not study pregnant females, prisoners, or institutionalized decisionally impaired patients.

Where it is running

• Chandler Hospital — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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