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Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults (ICUFeverAPAP)

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ClinicalTrials.gov Identifier: NCT01869699
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fever Critical Illness Drug: Acetaminophen Drug: Placebo Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults: a Randomized Controlled Trial
Study Start Date : September 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Placebo Comparator: Normal saline placebo
Normal saline 100 mLs intravenous, administered over 15 minutes
Drug: Placebo
Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
Other Names:
  • NS
  • 0.9% sodium chloride

Experimental: Acetaminophen
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Drug: Acetaminophen
acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
Other Name: Ofirmev




Primary Outcome Measures :
  1. Core Body Temperature [ Time Frame: Baseline to 4 hours post study drug administration ]
    time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes.


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: Baseline to 4 hours post study drug administration ]
    time-weighted average heart rate over 4 hours. Heart rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the heart rate values was divided by time in minutes.

  2. Systolic Blood Pressure [ Time Frame: Baseline to 4 hours post study drug administration ]
    time-weighted average systolic blood pressure over 4 hours. Systolic blood pressure was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the systolic blood pressure values was divided by time in minutes.

  3. Respiratory Rate [ Time Frame: Baseline to 4 hours post study drug administration ]
    time weighted average for respiratory rate over 4 hours. Respiratory rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the respiratory rate values was divided by time in minutes.

  4. 2-hour Change Over Time Core Temperature [ Time Frame: 2 hours ]
    change over time core temperature after study drug administration (adjusted to baseline core temperature)

  5. 2-hour Change Over Time Systolic Blood Pressure [ Time Frame: Baseline to 2 hours ]
    2-hour change over time SBP from study drug administration (means adjusted to baseline SBP)

  6. 2-hour Change Over Time Heart Rate [ Time Frame: Baseline to 2 hours ]
    2-hour change over time heart rate from time of study drug administration (means adjusted to baseline HR)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869699


Locations
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United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Kathleen A. Puntillo, PhD University of California, San Francisco

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01869699     History of Changes
Other Study ID Numbers: UCSF-ICUFever
First Posted: June 5, 2013    Key Record Dates
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
Fever
Acetaminophen
Critical Care
ICU
Febrile
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics