Effect of EPA and HMB on Strength in ICU Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Gerald Supinski, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01270516
First received: January 4, 2011
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Muscle Weakness
Drug: HMB, hydroxymethylbutyrate
Drug: EPA, eicosapentaenoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of EPA and HMB on Diaphragm and Limb Muscle Strength in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Improvement of skeletal muscle strength for one of the drugs compared to placebo [ Time Frame: By the second strength measurement (11 days) ] [ Designated as safety issue: No ]
    The primary outcome to be assessed is whether skeletal muscle strength (diaphragm and limb) is higher at the end of the administration trial (i.e. at 11 days) for patients given one or both of the active drugs (EPA or HMB) as compared to strength measurements at 11 days for patients given the placebo.


Secondary Outcome Measures:
  • duration of mechanical ventilation [ Time Frame: weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control, to be given saline solution
Intervention: This group will be given saline (30 ml every 12 hours) for 10 days
Experimental: EPA, eicosapentaenoic acid
This group will be given 1000 mg EPA every 12 hours for 10 days
Drug: EPA, eicosapentaenoic acid
EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
Other Name: This is an over the counter biopharmaceutical
Experimental: HMB, hydroxymethylbutyrate
This arm will be given HMB (1500 mg) every 12 hours for 10 days.
Drug: HMB, hydroxymethylbutyrate
Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days
Other Name: This agent is an over the counter biopharmaceutical
Experimental: EPA and HMB
This group will be given EPA (1000 mg every 12 hours given via the GI tract) and HMB (1500 mg every 12 hours given via the GI tract) for 10 days.
Drug: HMB, hydroxymethylbutyrate
Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days
Other Name: This agent is an over the counter biopharmaceutical
Drug: EPA, eicosapentaenoic acid
EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
Other Name: This is an over the counter biopharmaceutical

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270516

Contacts
Contact: Gerald Supinski, MD 859-494-3480 gsupi2@email.uky.edu
Contact: Leigh Ann Callahan, MD 7062311769 lacall2@email.uky.edu

Locations
United States, Kentucky
Chandler Hospital Recruiting
Lexington, Kentucky, United States, 40536
Contact: Gerald Supinski, MD    859-494-3480    gsupi2@email.uky.edu   
Principal Investigator: Gerald Supinski, MD         
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Gerald Supinski, MD University of Kentucky
  More Information

No publications provided

Responsible Party: Gerald Supinski, Professor of Medicine, University of Kentucky
ClinicalTrials.gov Identifier: NCT01270516     History of Changes
Other Study ID Numbers: Diaphragm EPA HMB
Study First Received: January 4, 2011
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
diaphragm
limb muscle
EPA
HMB
ICU patients

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014