Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage

• Status: Terminated
• Trial end date: 2016-03-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Cumberland Pharmaceuticals
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• 18 years of age or older

• Aneurysmal subarachnoid hemorrhage (SAH), Hunt Hess grade >= 3, 24 hours after admission.

• Intracerebral hemorrhage (ICH), Glasgow Coma Scale (GCS) < 10

• Presence of intraventricular hemorrhage on initial brain computerized tomography (CT) scan

Exclusion Criteria:

• Imminent death within 72 hours of admission.

• Plan for discharge from the Neuro intensive care unit (ICU) within 72 hours of admission.

• Diagnosis with sepsis (Systemic inflammatory response syndrome (SIRS) criteria plus the presence of known or suspected infection)

• Presence of coagulopathy (international normalized ratio (INR) > 1.7)

• Thrombocytopenia (platelet count < 100,000)

• History of gastrointestinal bleed

• Abnormal liver function tests (aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline phosphatase (AP)/Gamma-glutamyl transferase (GGT) 2x normal)

• Hypersensitivity to ibuprofen

• Pregnancy as determined by urine beta human chorionic gonadotropin (hCG), or lactating postpartum women

• Renal impairment (Creatinine > 1.5 mg/dL)

• Measured body weight < 50 kg