Status:
COMPLETED
Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults
Lead Sponsor:
University of California, San Francisco
Conditions:
Fever
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effects of intravenous acetaminophen to placebo on body temperature and hemodynamic (heart rate and blood pressure) responses in febrile critically ill adul...
Detailed Description
Adult patients with fever (≥ 38.3ºCentigrade (C)/101ºFarenheit(F)) in the intensive care unit will be screened for eligibility and approached for informed consent. Enrolled patients will be stratified...
Eligibility Criteria
Inclusion
- 18 years of age and older
- Patient in an intensive care unit
- Weight greater or equal to 50 kgs
- Fever: core body temperature greater than or equal to 38.3 degrees Celsius
- Clinically stable: no active resuscitation with fluids, blood products, or dose increases of vasoactive medications within 1 hour of study drug administration
Exclusion
- Acetaminophen hypersensitivity
- Acute liver failure or acute liver injury
- Heat stroke, malignant hyperthermia, neuroleptic malignant syndrome
- Therapeutic cooling, physical cooling, extracorporeal blood circuit therapies
- Administration of acetaminophen-containing medications, non-steroidal anti-inflammatory drugs, or aspirin greater than 81 mg within specified times per drug prior to fever presentation
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01869699
Start Date
September 1 2013
End Date
August 1 2015
Last Update
August 9 2017
Active Locations (2)
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1
UCSF Medical Center
San Francisco, California, United States, 94143
2
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143