Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage
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|ClinicalTrials.gov Identifier: NCT01530880|
Recruitment Status : Terminated (PI no longer at institution)
First Posted : February 10, 2012
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head injuries and is associated with poor recovery after injury. The current standard of care is to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can effectively reduce fever but results in a high rate of shivering. Shivering is stressful to the heart and can further worsen brain injury. Methods to combat shivering have been developed and are successful in limiting the stress in the majority of patients that use a body cooling device. However, the drugs used to control shivering are sedating and may also interfere with brain recovery.
The purpose of this study is to assess whether ibuprofen given intravenously is more effective in combating fever than the current standard of care. Should results from this study demonstrate that ibuprofen infusion is effective, a larger study will be conducted to determine whether this aggressive fever control regimen leads to improved recovery after brain injury.
|Condition or disease||Intervention/treatment||Phase|
|Fever||Drug: Intravenous Ibuprofen Drug: Acetaminophen (Standard of Care)||Phase 4|
This is an open-label, investigator initiated single center, randomized, prospective study. Subjects meeting enrollment criteria will be randomly assigned 1:1 to one of two groups:
- Standard Care: Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.
- Ibuprofen 400 mg/100 mL NS IV over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL NS at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.
Patients/surrogates will be approached for consent and randomized upon admission. Therapy will only be initiated once a patient becomes febrile (>=38.3 C, 100.9 F). The use of temperature modulating devices will be permitted as per institutionally approved guidelines in those patients continuing to demonstrate a fever (T>38.3 C, 100.9 F) with either therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 17, 2016|
|Actual Study Completion Date :||March 17, 2016|
Experimental: Intravenous Ibuprofen
Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.
Drug: Intravenous Ibuprofen
Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first
Other Name: Caldolor
Standard of Care
Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).
Drug: Acetaminophen (Standard of Care)
Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.
Other Name: Tylenol
- Prevalence of Fever Burden [ Time Frame: Up to14 days ]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.
- Mean Difference in Inflammatory Markers [ Time Frame: Up to 14 days ]Mean difference in markers of inflammation between IV ibuprofen and standard of care groups
- Difference in Cost Between Ibuprofen and Acetaminophen [ Time Frame: Up to 14 days ]Cost analysis of aggressive fever control (AFC) between patients randomized to either intravenous ibuprofen infusion or standard of care (oral acetaminophen).
- Bleeding Incidence [ Time Frame: Up to 14 days ]Incidence of bleeding (defined by a priori criteria)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530880
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||J. Michael Schmidt, MD||Columbia University|