Trial Outcomes & Findings for Statin Therapy in the Treatment of Sepsis (NCT NCT00676897)
NCT ID: NCT00676897
Last Updated: 2017-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
18 participants
Primary outcome timeframe
up to 7 days
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Statin Group
Simvastatin: Simvastatin 40mg PO or NGT
|
Placebo Group
Placebo: Corn Starch
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Statin Therapy in the Treatment of Sepsis
Baseline characteristics by cohort
| Measure |
Statin Group
n=8 Participants
Simvastatin: Simvastatin 40mg PO or NGT
|
Placebo Group
n=10 Participants
Placebo: Corn Starch
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 18 • n=99 Participants
|
54 years
STANDARD_DEVIATION 16 • n=107 Participants
|
58.72 years
STANDARD_DEVIATION 17.19 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 7 daysOutcome measures
| Measure |
Statin Group
n=8 Participants
Simvastatin: Simvastatin 40mg PO or NGT
|
Placebo Group
n=10 Participants
Placebo: Corn Starch
|
|---|---|---|
|
Time to Shock Reversal
|
44.4 hours
Standard Deviation 57.3
|
28.6 hours
Standard Deviation 34.5
|
SECONDARY outcome
Timeframe: over 24 hours (time zero and time 24 hours)Change in inflammatory marker levels over time from time zero to time 24 hour.
Outcome measures
| Measure |
Statin Group
n=8 Participants
Simvastatin: Simvastatin 40mg PO or NGT
|
Placebo Group
n=10 Participants
Placebo: Corn Starch
|
|---|---|---|
|
Inflammatory Marker Levels
VEGF (pg/mL)
|
-98 pg/mL and ng/mL
Standard Deviation 306
|
269 pg/mL and ng/mL
Standard Deviation 396
|
|
Inflammatory Marker Levels
IL-6 (pg/mL)
|
-370 pg/mL and ng/mL
Standard Deviation 698
|
-423 pg/mL and ng/mL
Standard Deviation 620
|
|
Inflammatory Marker Levels
TNF-alpha (pg/mL)
|
-0.52 pg/mL and ng/mL
Standard Deviation 26
|
-2.17 pg/mL and ng/mL
Standard Deviation 43
|
|
Inflammatory Marker Levels
ICAM (ng/mL)
|
148 pg/mL and ng/mL
Standard Deviation 282
|
-0.10 pg/mL and ng/mL
Standard Deviation 69
|
|
Inflammatory Marker Levels
VCAM (ng/mL)
|
1279 pg/mL and ng/mL
Standard Deviation 2275
|
190 pg/mL and ng/mL
Standard Deviation 1049
|
|
Inflammatory Marker Levels
eSelectin (ng/mL)
|
98 pg/mL and ng/mL
Standard Deviation 202
|
11 pg/mL and ng/mL
Standard Deviation 29
|
Adverse Events
Statin Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
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
Dr. Michael W. Donnino
Beth Israel Deaconess Medical Center
Phone: 6177542341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place