CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
HMB, hydroxymethylbutyrate +2 moredrug
Likely dose
HMB, hydroxymethylbutyrate 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01270516
NCT01270516N/ACompleted

Effect of EPA and HMB on Diaphragm and Limb Muscle Strength in Mechanically Ventilated Patients

Gerald Supinski·interventional·Posted Jan 5, 2011·Updated Apr 12, 2021

In Brief

A clinical study evaluating HMB, hydroxymethylbutyrate, EPA, eicosapentaenoic acid, and 1 other intervention for Muscle Weakness. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscle Weakness
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2011
Enrollment StartJan 1, 2014
Primary CompletionJan 20, 2020
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 15.5 years ago

Interventions

HMB, hydroxymethylbutyratedrug

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

EPA, eicosapentaenoic aciddrug

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

Salinedrug

Control