Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | August 2015 |
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.
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
2
sites
505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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