Trial Outcomes & Findings for Effect of EPA and HMB on Strength in ICU Patients (NCT NCT01270516)

Last Updated: 2021-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

By the second strength measurement (11 days)

Results posted on

2021-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Control, to be Given Saline Solution Intervention: This group will be given saline (30 ml every 12 hours) for 10 days Saline: Control	EPA, Eicosapentaenoic Acid This group will be given 1000 mg EPA every 12 hours for 10 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days	HMB, Hydroxymethylbutyrate This arm will be given HMB (1500 mg) every 12 hours for 10 days. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days	EPA and HMB 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. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
Overall Study STARTED	20	17	18	18
Overall Study COMPLETED	17	13	13	13
Overall Study NOT COMPLETED	3	4	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of EPA and HMB on Strength in ICU Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control, to be Given Saline Solution n=20 Participants Intervention: This group will be given saline (30 ml every 12 hours) for 10 days Saline: Control	EPA, Eicosapentaenoic Acid n=17 Participants This group will be given 1000 mg EPA every 12 hours for 10 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days	HMB, Hydroxymethylbutyrate n=18 Participants This arm will be given HMB (1500 mg) every 12 hours for 10 days. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days	EPA and HMB n=18 Participants 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. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants	13 Participants n=107 Participants	12 Participants n=206 Participants	14 Participants n=7 Participants	53 Participants n=31 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants	4 Participants n=7 Participants	20 Participants n=31 Participants
Age, Continuous	58 years n=99 Participants	57 years n=107 Participants	64 years n=206 Participants	60 years n=7 Participants	59 years n=31 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	11 Participants n=107 Participants	10 Participants n=206 Participants	6 Participants n=7 Participants	37 Participants n=31 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants	12 Participants n=7 Participants	36 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	2 Participants n=7 Participants	12 Participants n=31 Participants
Race (NIH/OMB) White	18 Participants n=99 Participants	13 Participants n=107 Participants	14 Participants n=206 Participants	15 Participants n=7 Participants	60 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Region of Enrollment United States	20 Participants n=99 Participants	17 Participants n=107 Participants	18 Participants n=206 Participants	18 Participants n=7 Participants	73 Participants n=31 Participants
Transdiaphragmatic pressure	6 cm H2O n=99 Participants	4.7 cm H2O n=107 Participants	3.3 cm H2O n=206 Participants	6 cm H2O n=7 Participants	5 cm H2O n=31 Participants

PRIMARY outcome

Timeframe: By the second strength measurement (11 days)

Population: Comparison of transdiaphragmatic twitch pressure (PdiTw), an index of strength, before and after treatment

Outcome measures

Outcome measures
Measure	Control, to be Given Saline Solution n=13 Participants Intervention: This group will be given saline (30 ml every 12 hours) for 10 days Saline: Control	EPA, Eicosapentaenoic Acid n=10 Participants This group will be given 1000 mg EPA every 12 hours for 10 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days	HMB, Hydroxymethylbutyrate n=9 Participants This arm will be given HMB (1500 mg) every 12 hours for 10 days. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days	EPA and HMB n=12 Participants 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. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo	1.3 cm H2O Interval 0.0 to 1.7	0.1 cm H2O Interval -1.4 to 3.2	1.5 cm H2O Interval 0.0 to 3.2	0.7 cm H2O Interval -1.8 to 3.7

SECONDARY outcome

Timeframe: Up to 50 Days

Total duration on mechanical ventilation up to 50 days after study entry. The number of subjects in each group for this section represent the numbers for whom it was possible to determine the duration of mechanical ventilation after completion of treatment regimens.

Outcome measures

Outcome measures
Measure	Control, to be Given Saline Solution n=13 Participants Intervention: This group will be given saline (30 ml every 12 hours) for 10 days Saline: Control	EPA, Eicosapentaenoic Acid n=10 Participants This group will be given 1000 mg EPA every 12 hours for 10 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days	HMB, Hydroxymethylbutyrate n=9 Participants This arm will be given HMB (1500 mg) every 12 hours for 10 days. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days	EPA and HMB n=12 Participants 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. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
Duration of Mechanical Ventilation	5 Days Interval 3.0 to 8.0	7 Days Interval 7.0 to 13.0	6 Days Interval 4.5 to 10.0	6 Days Interval 3.8 to 7.0

Adverse Events

Control, to be Given Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EPA, Eicosapentaenoic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

HMB, Hydroxymethylbutyrate

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

EPA and HMB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Control, to be Given Saline Solution n=20 participants at risk Intervention: This group will be given saline (30 ml every 12 hours) for 10 days Saline: Control	EPA, Eicosapentaenoic Acid n=17 participants at risk This group will be given 1000 mg EPA every 12 hours for 10 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days	HMB, Hydroxymethylbutyrate n=18 participants at risk This arm will be given HMB (1500 mg) every 12 hours for 10 days. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days	EPA and HMB n=18 participants at risk 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. HMB, hydroxymethylbutyrate: Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days EPA, eicosapentaenoic acid: EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
Musculoskeletal and connective tissue disorders Leg hematoma	0.00% 0/20 • Adverse event information was collected over the time the patient was in the study, i.e. the 10 days during which treatments were being given. Adverse events included all deaths and any unusual event during the time of study treatment. All adverse events were reported and reviewed by the University of Kentucky Clinical Translational Center Data Safety and Monitoring Board. The patients in this study were seriously ill, with a high predicted mortality. The deaths that occurred in this population were expected based on their clinical presentations, and all had failure of one or more organ systems.	0.00% 0/17 • Adverse event information was collected over the time the patient was in the study, i.e. the 10 days during which treatments were being given. Adverse events included all deaths and any unusual event during the time of study treatment. All adverse events were reported and reviewed by the University of Kentucky Clinical Translational Center Data Safety and Monitoring Board. The patients in this study were seriously ill, with a high predicted mortality. The deaths that occurred in this population were expected based on their clinical presentations, and all had failure of one or more organ systems.	5.6% 1/18 • Number of events 1 • Adverse event information was collected over the time the patient was in the study, i.e. the 10 days during which treatments were being given. Adverse events included all deaths and any unusual event during the time of study treatment. All adverse events were reported and reviewed by the University of Kentucky Clinical Translational Center Data Safety and Monitoring Board. The patients in this study were seriously ill, with a high predicted mortality. The deaths that occurred in this population were expected based on their clinical presentations, and all had failure of one or more organ systems.	0.00% 0/18 • Adverse event information was collected over the time the patient was in the study, i.e. the 10 days during which treatments were being given. Adverse events included all deaths and any unusual event during the time of study treatment. All adverse events were reported and reviewed by the University of Kentucky Clinical Translational Center Data Safety and Monitoring Board. The patients in this study were seriously ill, with a high predicted mortality. The deaths that occurred in this population were expected based on their clinical presentations, and all had failure of one or more organ systems.

Other adverse events

Adverse event data not reported

Additional Information

Emily Bradford, Clinical Trial Compliance Administrator

University of Kentucky

Phone: 859) 323-2973

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place