The Fever and Antipyretic in Critically Illness Evaluation Study

Overview

The purpose of this multination multicenter observational study is to determine the impact of fever and antipyretic on outcomes in critically ill patients.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2009

Detailed Description

Fever is common in critically ill patients.Antipyretic therapy for fever is routinely performed in intensive care.There are studies to assess the relationship between fever and mortality in non-neurological ICU. However, all of them did not have any information of antipyretic therapy. There are two small, single center RCT, which suggested a potential risk for antipyretic therapy. Thus, a large RCT might be ethically difficult. It is unfortunate that there is not enough information on how the investigators should control body temperature in non-neurological critically ill patients, because fever is a very common physiological abnormality in this cohort. From the beginning, it would, therefore, be desirable to understand several aspects of fever and antipyretic therapy in ICU patients, as 1)How often fever occurs in our ICUs, 2)To what degree fever is independently associated with mortality?, 3)How often antipyretic therapy is prescribed?, 4)How effectively antipyretic can decrease temperature?, 5)How different is lowering temperature with medications compared with cooling?, 6)To what degree antipyretic is independently associated with mortality? Thus, the investigators plan to address these questions by conducting a multi-national multi-center prospective observational trial, named "The Fever and Antipyretic in Critically illness evaluation study" (The FACE study)

Interventions

  • Other: Antipyretic therapy
    • External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid

Arms, Groups and Cohorts

  • Patients with fever
  • Patients without any fever

Clinical Trial Outcome Measures

Primary Measures

  • 28 days mortality
    • Time Frame: 28days after ICU admission

Secondary Measures

  • ICU free days at 28 days
    • Time Frame: 28 days after ICU admission
  • Hospital free days at 28 days
    • Time Frame: 28 days
  • Ventilator free days at 28 days
    • Time Frame: 28 days at ICU admission
  • Renal replacement therapy free days at 28 days
    • Time Frame: 28 days at ICU admission

Participating in This Clinical Trial

Inclusion Criteria

  • Adult non-neurological critically ill patients (20 years old or older). – ICU patients expected to require intensive care for more than 48 hour. Exclusion Criteria:

  • Patients with brain injury (suspected or proven)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Japanese Society of Intensive Care Medicine
  • Provider of Information About this Clinical Study
    • Japanese Society of Intensive Care Medicine, Japanese Society of Intensive Care Medicine
  • Overall Official(s)
    • Younsuck Koh, M.D. PhD, Study Chair, Korean Society of Critical Care Medicine
    • Masaji Nishimura, M.D. PhD, Study Chair, Japanese Society of Intensive Care Medicine
    • Jae Yeol Kim, M.D., Principal Investigator, Korean Society of Critical Care Medicine
    • Gee Young Suh, M.D., Principal Investigator, Korean Society of Critical Care Medicine
    • Moritoki Egi, M.D., Principal Investigator, Japanese Society of Intensive Care Medicine

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