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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Columbia University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01530880
First received: February 8, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Fever
Drug: Intravenous Ibuprofen
Drug: Acetaminophen (Standard of Care)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Fever Burden [ Time Frame: Up to14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Inflammatory Markers [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    Mean difference in markers of inflammation between IV ibuprofen and standard of care groups

  • Cost analysis [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Incidence of bleeding (defined by a priori criteria)


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Ibuprofen Drug: Intravenous Ibuprofen
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
Other Name: Caldolor
Standard of Care 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530880

Contacts
Contact: Neeraj Badjatia, MD 212-305-7236 nb2217@columbia.edu
Contact: Christine Lesch, PharmD 212-305-8745 cal9005@nyp.org

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Neeraj Badjatia, MD         
Sponsors and Collaborators
Columbia University
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Neeraj Badjatia, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01530880     History of Changes
Other Study ID Numbers: AAAI1788
Study First Received: February 8, 2012
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Fever reduction
Fever burden
intravenous ibuprofen

Additional relevant MeSH terms:
Fever
Cerebral Hemorrhage
Hemorrhage
Body Temperature Changes
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Acetaminophen
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014