Trial · NCT00978419
Pilot Trial of Statin Use in Burn Patients
NCT00978419, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2018-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Trial of Statin Use in Burn Patients. Trials, record NCT00978419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00978419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Trial of Statin Use in Burn Patients
- NCT number
- NCT00978419
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Burns
- Interventions
- Rosuvastatin, Placebo
- First posted
- 2009-09-16
- Last updated
- 2018-06-01
- Results first posted
- 2018-06-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoint: Reduction in CRP Level Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14. The Mean CRP Levels at Specified Days Will be the Endpoints. | Days 1, 3, 7, 14 | |
| Secondary | Mortality Compared to Placebo | 90 days | |
| Secondary | Mortality Compared to Placebo, Adjusted for Cardiovascular Co-morbidities | 90 days | |
| Secondary | Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo | 28 days | |
| Secondary | Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo, Adjusted for Cardiovascular Co-morbidities | 28 days | |
| Secondary | A Reduction in CK Levels Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14, 21, 28 | 28 days | |
| Secondary | A Reduction in ALT Levels Over Time, Compared to Placebo, Measured at Baseline, Days 1, 7, 14, 21, 28 | 28 days | |
| Secondary | Determine the Safety of Rosuvastatin Compared to Placebo in Burn Patients by Comparing the Frequency, Type and Severity of Adverse Events | 28 days | |
| Secondary | Determine Which Are Appropriate Attainable Endpoints for Future Trials and the Number of Participants Required to Reach Significance in Analysis of a Variety of Variables | 28 days | |
| Secondary | Determine the Prevalence of Delirium in the Two Subgroup of Patients | 28 days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Endpoint: Reduction in CRP Level Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14. The Mean CRP Levels at Specified Days Will be the Endpoints. | Days 1, 3, 7, 14 | |||
| SECONDARY | Mortality Compared to Placebo | 90 days | |||
| SECONDARY | Mortality Compared to Placebo, Adjusted for Cardiovascular Co-morbidities | 90 days | |||
| SECONDARY | Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo | 28 days | |||
| SECONDARY | Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo, Adjusted for Cardiovascular Co-morbidities | 28 days | |||
| SECONDARY | A Reduction in CK Levels Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14, 21, 28 | 28 days | |||
| SECONDARY | A Reduction in ALT Levels Over Time, Compared to Placebo, Measured at Baseline, Days 1, 7, 14, 21, 28 | 28 days | |||
| SECONDARY | Determine the Safety of Rosuvastatin Compared to Placebo in Burn Patients by Comparing the Frequency, Type and Severity of Adverse Events | 28 days | |||
| SECONDARY | Determine Which Are Appropriate Attainable Endpoints for Future Trials and the Number of Participants Required to Reach Significance in Analysis of a Variety of Variables | 28 days | |||
| SECONDARY | Determine the Prevalence of Delirium in the Two Subgroup of Patients | 28 days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosuvastatin | 0 | |
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | COMPLETED | Rosuvastatin | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rosuvastatin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin | 0 | 0 |
| Total, all-cause mortality | Placebo | 0 | 0 |
| Total, other adverse events | Rosuvastatin | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Rosuvastatin | 0 | 0 |
| Total, serious adverse events | Placebo | 0 | 0 |
Source ClinicalTrials.gov
Papers49
The papers the trial lists on ClinicalTrials.gov.
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/NCT00978419
GET https://conductscience.org/api/trials/v1/NCT00978419/papers?page=2