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Effect of EPA and HMB on Strength in ICU Patients

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ClinicalTrials.gov Identifier: NCT01270516
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Gerald Supinski, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muscle Weakness
Interventions Drug: HMB, hydroxymethylbutyrate
Drug: EPA, eicosapentaenoic acid
Drug: Saline
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Hide Arm/Group Description

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

Saline: Control

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

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

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

Period Title: Overall Study
Started 20 17 18 18
Completed 17 13 13 13
Not Completed 3 4 5 5
Arm/Group Title Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB Total
Hide Arm/Group Description

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

Saline: Control

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

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

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 of all reporting groups
Overall Number of Baseline Participants 20 17 18 18 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 17 participants 18 participants 18 participants 73 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  70.0%
13
  76.5%
12
  66.7%
14
  77.8%
53
  72.6%
>=65 years
6
  30.0%
4
  23.5%
6
  33.3%
4
  22.2%
20
  27.4%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 20 participants 17 participants 18 participants 18 participants 73 participants
58
(44 to 69)
57
(40 to 65)
64
(51 to 69)
60
(46 to 64)
59
(49 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 17 participants 18 participants 18 participants 73 participants
Female
10
  50.0%
11
  64.7%
10
  55.6%
6
  33.3%
37
  50.7%
Male
10
  50.0%
6
  35.3%
8
  44.4%
12
  66.7%
36
  49.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 17 participants 18 participants 18 participants 73 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  10.0%
4
  23.5%
4
  22.2%
2
  11.1%
12
  16.4%
White
18
  90.0%
13
  76.5%
14
  77.8%
15
  83.3%
60
  82.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 17 participants 18 participants 18 participants 73 participants
20
 100.0%
17
 100.0%
18
 100.0%
18
 100.0%
73
 100.0%
Transdiaphragmatic pressure  
Median (Inter-Quartile Range)
Unit of measure:  Cm H2O
Number Analyzed 20 participants 17 participants 18 participants 18 participants 73 participants
6
(4 to 9)
4.7
(4 to 7)
3.3
(2 to 4.7)
6
(3 to 8)
5
(3 to 7)
1.Primary Outcome
Title Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo
Hide Description

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.

Time Frame By the second strength measurement (11 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of transdiaphragmatic twitch pressure (PdiTw), an index of strength, before and after treatment
Arm/Group Title Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Hide Arm/Group Description:

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

Saline: Control

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

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

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 Number of Participants Analyzed 13 10 9 12
Median (Inter-Quartile Range)
Unit of Measure: cm H2O
1.3
(0 to 1.7)
0.1
(-1.4 to 3.2)
1.5
(0 to 3.2)
0.7
(-1.8 to 3.7)
2.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description 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.
Time Frame Up to 50 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Hide Arm/Group Description:

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

Saline: Control

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

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

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 Number of Participants Analyzed 13 10 9 12
Median (Inter-Quartile Range)
Unit of Measure: Days
5
(3 to 8)
7
(7 to 13)
6
(4.5 to 10)
6
(3.8 to 7)
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Hide Arm/Group Description

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

Saline: Control

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

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

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

All-Cause Mortality
Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      2/17 (11.76%)      1/18 (5.56%)      2/18 (11.11%)    
Hide Serious Adverse Events
Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/17 (0.00%)      1/18 (5.56%)      0/18 (0.00%)    
Musculoskeletal and connective tissue disorders         
Leg hematoma  [1]  0/20 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
One patient developed a leg hematoma two days after the initial set of measurements. This patient, however, also developed other limb hematomas several weeks after the study was over.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control, to be Given Saline Solution EPA, Eicosapentaenoic Acid HMB, Hydroxymethylbutyrate EPA and HMB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emily Bradford, Clinical Trial Compliance Administrator
Organization: University of Kentucky
Phone: 859) 323-2973
EMail: emily.bradford@uky.edu
Layout table for additonal information
Responsible Party: Gerald Supinski, University of Kentucky
ClinicalTrials.gov Identifier: NCT01270516    
Other Study ID Numbers: Diaphragm EPA HMB
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: February 18, 2021
Results First Posted: April 12, 2021
Last Update Posted: April 12, 2021