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

Fever research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fever

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intravenous IbuprofenIbuprofen 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

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intravenous IbuprofenPatients 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.

Standard of CarePatients 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).

Study Status

Terminated

Start Date: October 2012

Completed Date: March 17, 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Prevalence of Fever Burden

Secondary Outcome: Mean Difference in Inflammatory Markers

Study sponsors, principal investigator, and references

Principal Investigator: J. Michael Schmidt, MD

Lead Sponsor: Columbia University

Collaborator: Cumberland Pharmaceuticals

More information:https://clinicaltrials.gov/show/NCT01530880

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