Status:
COMPLETED
Anti-pyretic Therapy in Critically Ill Adults
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Intensive Care Foundation
Conditions:
Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The impact of fever and its management in different medical and surgical populations of critically ill patients has not been explained to date. The current study aims to assess the safety and efficacy...
Detailed Description
The impact of fever and its management in different medical and surgical populations of critically ill patients has not been explained to date. Clinical trials in critically ill surgical patients have...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Fever (two consecutive measurements ≥ 38.3°C at least 2 hours apart or a single temperature measurement ≥ 39.5°C)
- Admitted to ICU with an expected length of stay at least 48 hours related to critical illness
- Attending physician approval
Exclusion
- Admission to ICU for support for specific procedure (e.g. endoscopy, acute dialysis, bronchoscopy)
- Acute brain injury due to any etiology
- Acute myocardial ischemia
- Documented hepatitis with elevated alanine aminotransferase (ALT) more than twice the upper limit of normal, or chronic hepatic failure (defined by evidence of cirrhosis on available imaging or known varices, ascites, hepatic encephalopathy, hepatorenal syndrome, and/or hepatocellular carcinoma)
- Hyperthermia syndromes (malignant hyperthermia, heat stroke, neuroleptic malignant syndrome, serotonin syndrome, or endocrine causes including thyrotoxicosis, pheochromocytoma, and adrenal crisis)
- Refractory shock with lactic acidosis \>4 mmol/L (at the time of screening for study enrollment) despite supportive therapy or need for paralytic treatment to reduce metabolic demand
- Requirement for use of anti-pyretic agents (acetaminophen or NSAIDs) for indications other than treatment of fever
- Receipt of anti-pyretic pharmacotherapy within 6-hours of expected study enrollment (650mg acetaminophen, 800mg ibuprofen, or 325mg acetylsalicylic acid)
- Contraindications to esophageal temperature monitoring
- Pregnancy (all women of child-bearing potential need to have a pregnancy test performed prior to enrollment)
- Time from onset of fever in the ICU to consideration for study enrollment is \> 12 hours
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01173367
Start Date
August 1 2010
End Date
January 1 2012
Last Update
February 23 2012
Active Locations (2)
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1
Intensive Care Unit, Peter Lougheed Center
Calgary, Alberta, Canada, T1Y 6J4
2
Intensive Care Unit, Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9