Effect of EPA and HMB on Strength in ICU Patients

NCT01270516 | Completed Results DMC

• 1 other identifier: Diaphragm EPA HMB
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Weakness

Keywords

diaphragm; limb muscle; EPA; HMB; ICU patients

Outcome Measures

Primary Outcomes (1)

• Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo

  The primary outcome to be assessed is whether skeletal muscle strength (diaphragm and limb) has changed 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. The number of subjects in each group for this section represent the numbers for whom it was possible to measure trans-diaphragmatic pressure after completion of treatment regimens and thereby calculate a change in this parameter.

  By the second strength measurement (11 days)

Secondary Outcomes (1)

• Duration of Mechanical Ventilation

  Up to 50 Days

Study Arms (4)

Control, to be given saline solution

PLACEBO COMPARATOR

Intervention: This group will be given saline (30 ml every 12 hours) for 10 days

Drug: Saline

EPA, eicosapentaenoic acid

EXPERIMENTAL

This group will be given 1000 mg EPA every 12 hours for 10 days

Drug: EPA, eicosapentaenoic acid

HMB, hydroxymethylbutyrate

EXPERIMENTAL

This arm will be given HMB (1500 mg) every 12 hours for 10 days.

Drug: HMB, hydroxymethylbutyrate

EPA and HMB

EXPERIMENTAL

Intervention: 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; Drug: EPA, eicosapentaenoic acid

Interventions

HMB, hydroxymethylbutyrate DRUG

Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days

Also known as: This agent is an over the counter biopharmaceutical

EPA and HMB; HMB, hydroxymethylbutyrate

EPA, eicosapentaenoic acid DRUG

EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days

Also known as: This is an over the counter biopharmaceutical

EPA and HMB; EPA, eicosapentaenoic acid

Saline DRUG

Control

Also known as: Salt water

Control, to be given saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Gerald Supinski: lead

Study Sites (1)

Chandler Hospital

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• Supinski GS, Netzel PF, Westgate PM, Schroder EA, Wang L, Callahan LA. A randomized controlled trial to determine whether beta-hydroxy-beta-methylbutyrate and/or eicosapentaenoic acid improves diaphragm and quadriceps strength in critically Ill mechanically ventilated patients. Crit Care. 2021 Aug 26;25(1):308. doi: 10.1186/s13054-021-03737-9.

  PMID: 34446067 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Docosahexaenoic Acids; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Results Point of Contact

• Title: Emily Bradford, Clinical Trial Compliance Administrator
• Organization: University of Kentucky

emily.bradford@uky.edu

859) 323-2973

Study Officials

• Gerald Supinski, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: January 1, 2014
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: April 12, 2021
• Results First Posted: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)