Trial Outcomes & Findings for Pilot Trial of Statin Use in Burn Patients (NCT NCT00978419)

NCT ID: NCT00978419

Last Updated: 2018-06-01

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Days 1, 3, 7, 14

Results posted on

2018-06-01

Participant Flow

Both Principal Investigators left Vanderbilt without completing record. Have been unable to find any records from this study or publication. Total enrollment and completion date are from IRB records.

Participant milestones

Participant milestones
Measure
Rosuvastatin
Rosuvastatin Rosuvastatin: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days
Placebo
Placebo Placebo: Placebo administered every day for up to 28 days
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Trial of Statin Use in Burn Patients

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Days 1, 3, 7, 14

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome data not reported

Adverse Events

Rosuvastatin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Burn Unit Director

Vanderbilt University Medical Center

Phone: (615) 322-4590

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place