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

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fever; Critical Illness

Intervention: Acetaminophen (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Kathleen A. Puntillo, PhD, Principal Investigator, Affiliation: University of California, San Francisco

Overall contact:
Kathleen A Puntillo, PhD, Phone: 415-476-1844, Email: kathleen.puntillo@nursing.ucsf.edu

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.

Clinical Details

Official title: Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults: a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: core body temperature

Secondary outcome: heart rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Kathleen A Puntillo, PhD, Phone: 415-476-1844, Email: kathleen.puntillo@nursing.ucsf.edu

UCSF Medical Center, San Francisco, California 94143, United States; Recruiting
Hildegarde Schell-Chaple, PhD(c), Phone: 415-353-1039, Email: hildy.schell@ucsfmedctr.org
Kathleen Puntillo, PhD, Phone: 415-476-1844, Email: kathleen.puntillo@nursing.ucsf.edu
Kathleen Puntillo, PhD, Principal Investigator
Hildegarde Schell-Chaple, PhD(c), Sub-Investigator
Michael Matthay, MD, Sub-Investigator
Daniel Sessler, MD, Sub-Investigator

University of California, San Francisco Medical Center, San Francisco, California 94143, United States; Recruiting
Hildegarde Schell-Chaple, MS, Phone: 415-353-1039, Email: hildy.schell@ucsfmedctr.org
Hildegarde Schell-Chaple, PhD(c), Sub-Investigator
Kathleen Puntillo, PhD, Principal Investigator

Additional Information

Related publications:

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Lee BH, Inui D, Suh GY, Kim JY, Kwon JY, Park J, Tada K, Tanaka K, Ietsugu K, Uehara K, Dote K, Tajimi K, Morita K, Matsuo K, Hoshino K, Hosokawa K, Lee KH, Lee KM, Takatori M, Nishimura M, Sanui M, Ito M, Egi M, Honda N, Okayama N, Shime N, Tsuruta R, Nogami S, Yoon SH, Fujitani S, Koh SO, Takeda S, Saito S, Hong SJ, Yamamoto T, Yokoyama T, Yamaguchi T, Nishiyama T, Igarashi T, Kakihana Y, Koh Y; Fever and Antipyretic in Critically ill patients Evaluation (FACE) Study Group. Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study. Crit Care. 2012 Feb 28;16(1):R33. doi: 10.1186/cc11211. Erratum in: Crit Care. 2012;16(1):450.

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Starting date: September 2013
Last updated: June 3, 2014

Page last updated: August 23, 2015

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