Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Neurology, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2012 |
| End Date: | May 2013 |
| Contact: | Neeraj Badjatia, MD |
| Email: | nb2217@columbia.edu |
| Phone: | 212-305-7236 |
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.
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.
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:
1. 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.
2. 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.
Subjects meeting enrollment criteria will be randomly assigned 1:1 to one of two groups:
1. 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.
2. 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.
Inclusion Criteria:
- 18 years of age or older
- Aneurysmal subarachnoid hemorrhage (SAH), Hunt Hess grade >= 3, 24 hours after
admission.
- Intracerebral hemorrhage (ICH), GCS < 10
- Presence of intraventricular hemorrhage on initial brain CT scan
Exclusion Criteria:
- Imminent death within 72 hours of admission.
- Plan for discharge from the Neuro ICU within 72 hours of admission.
- Diagnosis with sepsis (SIRS criteria plus the presence of known or suspected
infection)
- Presence of coagulopathy (INR > 1.7)
- Thrombocytopenia (platelet count < 100,000)
- History of gastrointestinal bleed
- Abnormal liver function tests (AST/ALT/AP/GGT 2x normal)
- Hypersensitivity to ibuprofen
- Pregnancy as determined by urine beta Hcg, or lactating post partum women
- Renal impairment (Cr > 1.5 mg/dL)
- Measured body weight < 50 kg
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