Trial · NCT00979121
Statins for Acutely Injured Lungs From Sepsis
NCT00979121, Phase 3, Terminated, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2014-10-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Statins for Acutely Injured Lungs From Sepsis. Trials, record NCT00979121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00979121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Statins for Acutely Injured Lungs From Sepsis
- NCT number
- NCT00979121
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 745 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Sepsis, Acute Lung Injury
- Interventions
- Rosuvastatin, Placebo
- First posted
- 2009-09-17
- Last updated
- 2016-05-16
- Results first posted
- 2014-10-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hospital Mortality to Day 60. | 60 days after randomization | The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60. |
| Secondary | Ventilator Free Days at Study Day 28 | time of initiating unassisted breathing to day 28 after study randomization | Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given. |
| Other | Organ Failure Free Days at Day 14 | 14 days after randomization | The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function. |
| Other | ICU Free Days to Day 28 | 28 days after randomization | |
| Other | Other Secondary Out-comes | 28 days after randomization | Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured. |
| Other | Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14 | 6 and 14 days after randomization | CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hospital Mortality to Day 60. | 60 days after randomization | percentage of participants | NUMBER | |
| SECONDARY | Ventilator Free Days at Study Day 28 | time of initiating unassisted breathing to day 28 after study randomization | days | MEAN | |
| OTHER_PRE_SPECIFIED | Organ Failure Free Days at Day 14 | 14 days after randomization | days | MEAN | |
| OTHER_PRE_SPECIFIED | ICU Free Days to Day 28 | 28 days after randomization | days | MEAN | |
| OTHER_PRE_SPECIFIED | Other Secondary Out-comes | 28 days after randomization | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14 | 6 and 14 days after randomization | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hospital Mortality to Day 60. | Rosuvastatin | 28.5 | 95% Confidence Interval 24.0 to 33.0 | percentage of participants | |
| Hospital Mortality to Day 60. | Placebo | 24.9 | 95% Confidence Interval 20.5 to 29.3 | percentage of participants | |
| Ventilator Free Days at Study Day 28 | Rosuvastatin | 15.1 | Standard Deviation 10.8 | days | |
| Ventilator Free Days at Study Day 28 | Placebo | 15.1 | Standard Deviation 11.0 | days | |
| Organ Failure Free Days at Day 14 | Rosuvastatin | Cardiovascular | 8.5 | Standard Deviation 4.8 | days |
| Organ Failure Free Days at Day 14 | Placebo | Cardiovascular | 8.7 | Standard Deviation 4.9 | days |
| Organ Failure Free Days at Day 14 | Rosuvastatin | Coagulation | 10.7 | Standard Deviation 5.1 | days |
| Organ Failure Free Days at Day 14 | Placebo | Coagulation | 11.1 | Standard Deviation 4.8 | days |
| Organ Failure Free Days at Day 14 | Rosuvastatin | Hepatic | 10.8 | Standard Deviation 5.0 | days |
| Organ Failure Free Days at Day 14 | Placebo | Hepatic | 11.8 | Standard Deviation 4.3 | days |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosuvastatin | 379 | |
| Overall Study | STARTED | Placebo | 366 | |
| Overall Study | COMPLETED | Rosuvastatin | 379 | |
| Overall Study | COMPLETED | Placebo | 366 | |
| Overall Study | NOT COMPLETED | Rosuvastatin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events84
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 | Hemorrhage Retroperitoneal | General disorders | Rosuvastatin | 1 | 379 | 1 |
| serious | Hemorrhage Retroperitoneal | General disorders | Placebo | 1 | 366 | 1 |
| serious | Hyperpyrexia | General disorders | Rosuvastatin | 2 | 379 | 2 |
| serious | Hyperpyrexia | General disorders | Placebo | 0 | 366 | 0 |
| serious | Necrosis | General disorders | Rosuvastatin | 0 | 379 | 0 |
| serious | Necrosis | General disorders | Placebo | 1 | 366 | 1 |
| serious | Neuroleptic Malignant Syndrome | General disorders | Rosuvastatin | 1 | 379 | 1 |
| serious | Neuroleptic Malignant Syndrome | General disorders | Placebo | 0 | 366 | 0 |
| serious | Asystole | Cardiac disorders | Rosuvastatin | 0 | 379 | 0 |
| serious | Asystole | Cardiac disorders | Placebo | 1 | 366 | 1 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rosuvastatin | 0 | 379 |
| Total, other adverse events | Placebo | 0 | 366 |
| Total, serious adverse events | Rosuvastatin | 34 | 379 |
| Total, serious adverse events | Placebo | 32 | 366 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01HR056179 | Clin Coord Ctr for Clin Ntwrk Treatment of ARDS-268056179-268056179 | SCHOENFELD, DAVID | MASSACHUSETTS GENERAL HOSPITAL | DIVISION OF LUNG DISEASES | 2005 to 2006 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rosuvastatin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00979121
GET https://conductscience.org/api/trials/v1/NCT00979121/results?page=2