Trial · NCT01270516
Effect of EPA and HMB on Strength in ICU Patients
NCT01270516, Not applicable, Completed, Gerald Supinski; results first posted 2021-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of EPA and HMB on Strength in ICU Patients. Trials, record NCT01270516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01270516
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of EPA and HMB on Strength in ICU Patients
- NCT number
- NCT01270516
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 73 participants, actual
- Lead sponsor
- Gerald Supinski
- Conditions
- Muscle Weakness
- Interventions
- HMB, hydroxymethylbutyrate, EPA, eicosapentaenoic acid, Saline
- First posted
- 2011-01-05
- Last updated
- 2021-04-12
- Results first posted
- 2021-04-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo | By the second strength measurement (11 days) | 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. |
| Secondary | Duration of Mechanical Ventilation | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo | By the second strength measurement (11 days) | Comparison of transdiaphragmatic twitch pressure (PdiTw), an index of strength, before and after treatment | cm H2O | MEDIAN |
| SECONDARY | Duration of Mechanical Ventilation | Up to 50 Days | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo | Control, to be Given Saline Solution | 1.3 | Inter-Quartile Range 0 to 1.7 | cm H2O | |
| Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo | EPA, Eicosapentaenoic Acid | 0.1 | Inter-Quartile Range -1.4 to 3.2 | cm H2O | |
| Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo | HMB, Hydroxymethylbutyrate | 1.5 | Inter-Quartile Range 0 to 3.2 | cm H2O | |
| Change of Skeletal Muscle Strength for One of the Drugs Compared to Placebo | EPA and HMB | 0.7 | Inter-Quartile Range -1.8 to 3.7 | cm H2O | |
| Duration of Mechanical Ventilation | Control, to be Given Saline Solution | 5 | Inter-Quartile Range 3 to 8 | Days | |
| Duration of Mechanical Ventilation | EPA, Eicosapentaenoic Acid | 7 | Inter-Quartile Range 7 to 13 | Days | |
| Duration of Mechanical Ventilation | HMB, Hydroxymethylbutyrate | 6 | Inter-Quartile Range 4.5 to 10 | Days | |
| Duration of Mechanical Ventilation | EPA and HMB | 6 | Inter-Quartile Range 3.8 to 7 | Days |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control, to be Given Saline Solution | 20 | |
| Overall Study | STARTED | EPA, Eicosapentaenoic Acid | 17 | |
| Overall Study | STARTED | HMB, Hydroxymethylbutyrate | 18 | |
| Overall Study | STARTED | EPA and HMB | 18 | |
| Overall Study | COMPLETED | Control, to be Given Saline Solution | 17 | |
| Overall Study | COMPLETED | EPA, Eicosapentaenoic Acid | 13 | |
| Overall Study | COMPLETED | HMB, Hydroxymethylbutyrate | 13 | |
| Overall Study | COMPLETED | EPA and HMB | 13 | |
| Overall Study | NOT COMPLETED | Control, to be Given Saline Solution | 3 | |
| Overall Study | NOT COMPLETED | EPA, Eicosapentaenoic Acid | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Leg hematoma | Musculoskeletal and connective tissue disorders | Control, to be Given Saline Solution | 0 | 20 | 0 |
| serious | Leg hematoma | Musculoskeletal and connective tissue disorders | EPA, Eicosapentaenoic Acid | 0 | 17 | 0 |
| serious | Leg hematoma | Musculoskeletal and connective tissue disorders | HMB, Hydroxymethylbutyrate | 1 | 18 | 1 |
| serious | Leg hematoma | Musculoskeletal and connective tissue disorders | EPA and HMB | 0 | 18 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control, to be Given Saline Solution | 0 | 20 |
| Total, all-cause mortality | EPA, Eicosapentaenoic Acid | 2 | 17 |
| Total, all-cause mortality | HMB, Hydroxymethylbutyrate | 1 | 18 |
| Total, all-cause mortality | EPA and HMB | 2 | 18 |
| Total, other adverse events | Control, to be Given Saline Solution | 0 | 20 |
| Total, other adverse events | EPA, Eicosapentaenoic Acid | 0 | 17 |
| Total, other adverse events | HMB, Hydroxymethylbutyrate | 0 | 18 |
| Total, other adverse events | EPA and HMB | 0 | 18 |
| Total, serious adverse events | Control, to be Given Saline Solution | 0 | 20 |
| Total, serious adverse events | EPA, Eicosapentaenoic Acid | 0 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34446067 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01270516
GET https://conductscience.org/api/trials/v1/NCT01270516/registered