Status:
TERMINATED
Safety and Efficacy of Acetaminophen in the Intensive Care Unit.
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Vancouver Coastal Health Research Institute
Conditions:
Critical Illness
Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The intensive care unit (ICU) team needs to know what effects acetaminophen has in critically ill patients. Acetaminophen is better known as Tylenol. It is the drug given to reduce fever. Most researc...
Detailed Description
In the ICU, fever is commonly treated with 650 mg acetaminophen every 4 hours with the hopes of reducing fever burden, thereby also reducing metabolic demand. Acetaminophen is thought to be a safe and...
Eligibility Criteria
Inclusion
- Generally to be considered for this study one must be critically ill, febrile, and can safely either receive acetaminophen or have acetaminophen withheld. Also one must not have conditions that would alter normal drug absorption or normal thermoregulation. Specifically the eligibility criteria are:
- INCLUSION CRITERIA:
- Adult patients (\> 18 years) admitted to Intensive Care Unit at Vancouver Hospital with a core temperature \> 38.3 °C for 2 or more consecutive hours, but not longer than 48 hours\*
- Continuous arterial pressure monitor in place at the time of intervention and data collection
- Patients may only participate in the study once
- To remain in the ICU for the entire study period (2 hours prior to drug administration to 4 hours post drug administration)
- EXCLUSION CRITERIA:
- Significant liver dysfunction
- Acute neurological injury
- Seizure disorder
- Cardiomyopathy, elevated cardiac enzymes indicative of an acute cardiac injury, electrocardiogram (ECG) changes indicative of cardiac ischemia (i.e., ST segment elevation/depression)
- Hemodynamic instability (requiring fluid boluses, or change/initiation of vasopressors. Patients receiving steady doses of vasopressor support may be included)
- Severe hypoxemia, (fraction of inspired oxygen (FiO2) requirements of more than 60% to maintain hemoglobin oxygen saturation (SaO2) \> 90% or partial pressure of oxygen in the blood (PaO2) \> 70)
- Temperature \> 40.0 °C
- Receiving external cooling
- Haemodialysis, plasma exchange, or any treatment where the blood is taken out of the body and processed
- Acute thermal injury to skin (i.e., burn)
- Gut malabsorption (i.e., receiving \< 40% required calories enterally)
- Receiving medications that have known antipyretic effects (acetaminophen, ibuprofen, steroids, etc.)
- Physician opposed to enrolment in the study
- NOTE: in response to very low enrollment 2 exclusion criteria were changed on Nov 5, 2015. These were:
- patients no longer needed to recieve 40% of required calories enterally, instead patients who were not receiving any caloric intake via the gut could be enrolled as long as they were still permitted to receive oral medications.
- patients no longer had to have acetaminophen discontinued upon enrollment. They could not be receiving it regularly but could still receive acetaminophen on an as needed (PRN) basis as long as it could be safely withheld for up to 12 hours if they developed a fever.
Exclusion
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02280239
Start Date
May 1 2015
End Date
February 1 2016
Last Update
November 4 2022
Active Locations (1)
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1
Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 1M9