Critical Illness Clinical Trial
Official title:
Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults: a Randomized Controlled Trial
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 adult patients.
There are limited data to explain the variable and unpredictable antipyretic and hemodynamic
response to acetaminophen in febrile ICU patients. The complex pathophysiology of critically
ill patients, co-morbid conditions, the effect of multiple pharmacologic and
non-pharmacologic care interventions, and/or the potential interferences with absorption of
enteral or rectal formulations may be related to variations in the antipyretic response to
acetaminophen. It is necessary for clinicians to have a better understanding of the therapy
response and potential adverse effects of this commonly administered medication, especially
the recently available IV formulation, in critically ill patients. Further research of the
antipyretic response to acetaminophen in critically ill patients is warranted to inform
evidence-based practice guidelines for fever management. Further randomized,
placebo-controlled studies of hemodynamic responses to IV acetaminophen are also warranted.
Primary Hypothesis:
There is a significant reduction in time-weighted average core body temperature over 4 hours
after administration of IV acetaminophen compared to placebo in febrile critically ill
patients.
Secondary Hypotheses:
1. There is a significant reduction in time-weighted average heart rate over 4 hours after
administration of IV acetaminophen compared to placebo in febrile critically ill
patients.
2. There is a significant reduction in time-weighted mean arterial pressure over 4 hours
after administration of IV acetaminophen compared to placebo in febrile critically ill
patients.
Adult patients with fever (≥ 38.3ºCentigrade/101ºFarenheit) in the intensive care unit will
be screened for eligibility and enrolled after informed consent. Patients will be randomized
to receive IV acetaminophen 1 gram or normal saline 100 mLs. Body temperature, heart rate,
and blood pressure will be measured at baseline and during the 4 hours post study drug
administration.
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 based on the leading etiology of their fever: either neurologic injury or infection and then randomized to receive IV acetaminophen 1 gram or normal saline 100 milliliters (mLs). Core body temperature will be measured using a zero-heat flow thermometry system (non-invasive, small disk on forehead). Patients will be monitored and data collected during the 4-hour post study drug administration period. A rescue protocol will be implemented if the temperature reaches ≥ 40 ºC during the study period and includes notification of primary team provider by the nurse and the pharmacist will contact them to inform the provider of study group (acetaminophen or placebo). The provider can decide whether to order antipyretic medication or physical cooling interventions at that time. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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