The Fever and Antipyretic in Critically Illness Evaluation Study (FACE)

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

Study Overview

• Status: Completed
• Conditions: Hyperthermia; Fever
• Intervention / Treatment: Other: Antipyretic therapy

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)

• Study Type: Observational
• Enrollment (Actual): 1426

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-0033
      • The Japanese Society of Intensive Care Medicine
• Korea, Republic of
  • Seoul
    • Songpa-gu, Seoul, Korea, Republic of, 138-736
      • Korean Society of Critical Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult non-neurological critically ill patients required intensive care for more than 48 hour.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with fever	Other: Antipyretic therapy; External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid; Other Names: Acetaminophen; Steroid; Others; External cooling; Internal cooling; Non steroid anti inflammatory drugs
Patients without any fever

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28 days mortality	28days after ICU admission

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU free days at 28 days	28 days after ICU admission
Hospital free days at 28 days	28 days
Ventilator free days at 28 days	28 days at ICU admission
Renal replacement therapy free days at 28 days	28 days at ICU admission

Collaborators and Investigators

• Sponsor: Japanese Society of Intensive Care Medicine
• Investigators: Study Chair: Younsuck Koh, M.D. PhD, Korean Society of Critical Care Medicine; Study Chair: Masaji Nishimura, M.D. PhD, Japanese Society of Intensive Care Medicine; Principal Investigator: Jae Yeol Kim, M.D., Korean Society of Critical Care Medicine; Principal Investigator: Gee Young Suh, M.D., Korean Society of Critical Care Medicine; Principal Investigator: Moritoki Egi, M.D., Japanese Society of Intensive Care Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• JSICM

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 16, 2009

Study Record Updates

• Last Update Posted (Estimate): May 19, 2010
• Last Update Submitted That Met QC Criteria: May 18, 2010
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Infection; ICU; Fever; Mortality; Steroid; Cooling; Acetaminophen; Intensive care; Critically ill; Antipyretic; Non steroid anti inflammatory drugs
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Acetaminophen; Antipyretics
• Other Study ID Numbers: JSICM&KSCCM FACE