Trial Outcomes & Findings for Statins for the Early Treatment of Sepsis (NCT NCT00528580)
NCT ID: NCT00528580
Last Updated: 2018-09-05
Results Overview
Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
24 hours
Results posted on
2018-09-05
Participant Flow
Patients enrolled 2008-2009 at University of Chicago and Mercy Hosptial in Chicago, IL
Participant milestones
| Measure |
Experimental
Simvastatin 80 mg once daily PO (or via NG or G-tube)
Simvastatin: 80 mg once daily PO/NG x 4 days
|
Placebo
Identical-appearing placebo PO (or via NG or G-tube)
Identical-appearing placebo: once daily x 4 days
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Statins for the Early Treatment of Sepsis
Baseline characteristics by cohort
| Measure |
Experimental
n=34 Participants
Simvastatin 80 mg once daily PO (or via NG or G-tube)
Simvastatin: 80 mg once daily PO/NG x 4 days
|
Placebo
n=34 Participants
Identical-appearing placebo PO (or via NG or G-tube)
Identical-appearing placebo: once daily x 4 days
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 8 • n=93 Participants
|
52 years
STANDARD_DEVIATION 8 • n=4 Participants
|
52 years
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNormalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.
Outcome measures
| Measure |
Treatment Group
n=34 Participants
Simvastatin 80 mg once daily PO (or via NG or G-tube)
Simvastatin: 80 mg once daily PO/NG x 4 days
|
Control Group
n=34 Participants
Identical-appearing placebo PO (or via NG or G-tube)
Identical-appearing placebo: once daily x 4 days
|
|---|---|---|
|
Time to Clinical Stability
|
3 days
Standard Error 1
|
3 days
Standard Error 1
|
Adverse Events
Simvastatin
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place