Overview

Safety and Efficacy of Acetaminophen in the Intensive Care Unit.

Status:
Terminated
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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 research that has looked at how safe and effective this drug is, has been done with healthy people. Those studies tell us it is safe and works well to bring down fever. This may not be true for the ICU patient. Some research found acetaminophen was not as good at reducing fever as expected in the ICU. Fever helps to fight infection so it may help patients get better, but it is also stressful. When you have fever, you to need more oxygen, and your heart beats faster. If you have a fever after brain injury, you are less likely to make a full recovery. In patients with brain injury, a weak heart or trouble breathing we should treat fever. If we can predict how well acetaminophen will reduce fever, we can decide if this drug is enough, or other treatments are also needed. If you do not have problems with your brain, heart, or lungs, it is safe to not treat fever. When you give this drug to treat fever, the body cools itself by sweating, and bringing hot blood to the skin's surface. These changes do not affect healthy people. Research suggests ICU patients may be at risk for sudden drop in blood pressure. Our study will answer 2 questions: 1) When acetaminophen is given to treat fever in ICU patients, are they more likely to have a drop in blood pressure? 2) How much will acetaminophen reduce fever in ICU patients? We will study ICU patients with a fever who can safely get, or not get this drug. This information will help us decide when and how to treat fever in the ICU.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of British Columbia
Collaborator:
Vancouver Coastal Health Research Institute
Treatments:
Acetaminophen
Criteria
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