Clinical trial NCT02280239: Safety and Efficacy of Acetaminophen in the Intensive Care Unit.
Official title: Safety and Antipyretic Efficacy of Acetaminophen in the Febrile Intensive Care Unit Patient.
Conditions: Critical Illness
Fever
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.
Interventions:
description: one-time dose of acetaminophen 650mg given via the enteral route (via the gut)
name: Acetaminophen
other_name: Tylenol
type: Drug
description: one-time dose of placebo (identical capsule) given via the enteral route (via the gut)
name: Placebo
other_name: Pharmacy compounded look alike capsule to the study drug
type: Drug
Study arms:
design_group_description: This group consists of stable but febrile ICU patients (temp >38.3°C). Participants in this group will receive a one-time dose of placebo via the enteral route (via the gut), after which vital signs (including continuous measures of core temperature, heart rate, and blood pressure) will be monitored for 4 hours.
design_group_title: Control Group
design_group_type: Placebo Comparator
design_group_description: This group consists of stable but febrile ICU patients (temp >38.3°C). Participants in this group will receive a one-time does of acetaminophen 650mg via the enteral route (via the gut), after which vital signs (including continuous measures of core temperature, heart rate, and blood pressure) will be monitored for 4 hours.
design_group_title: Acetaminophen Group
design_group_type: Experimental
Sponsor: University of British Columbia
Collaborators: Vancouver Coastal Health Research Institute
Drug name mappings:
name: 对乙酰氨基酚
lang: CN
name: Acetaminophen
lang: EN
name: アセトアミノフェン
lang: JP