Trial Outcomes & Findings for Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage (NCT NCT01530880)
NCT ID: NCT01530880
Last Updated: 2017-08-28
Results Overview
Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.
TERMINATED
PHASE4
35 participants
Up to14 days
2017-08-28
Participant Flow
Participant milestones
| Measure |
All Subjects
Includes subjects from both arms as this information is only available for all subjects and not per arm.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage
Baseline characteristics by cohort
| Measure |
All Subjects
n=35 Participants
Includes subjects from both arms.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to14 daysPopulation: PI left before data could be analyzed and data collection was incomplete.
Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: PI left before data could be analyzed and data collection was incomplete.
Mean difference in markers of inflammation between IV ibuprofen and standard of care groups
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: PI left before data could be analyzed and data collection was incomplete.
Cost analysis of aggressive fever control (AFC) between patients randomized to either intravenous ibuprofen infusion or standard of care (oral acetaminophen).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: PI left before data could be analyzed and data collection was incomplete.
Incidence of bleeding (defined by a priori criteria)
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
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