Clinical trial NCT00940654: The Fever and Antipyretic in Critically Illness Evaluation Study
Official title: The Fever and Antipyretic in Critically Illness Evaluation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Hyperthermia
Keywords: Fever
Antipyretic
Infection
Mortality
Cooling
Non steroid anti inflammatory drugs
Acetaminophen
Steroid
ICU
Intensive care
Critically ill
Lead sponsor: Japanese Society of Intensive Care Medicine
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 1426
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult non-neurological critically ill patients required intensive care for more than 48 hour.

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

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)

Eligibility criteria: 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)

Primary outcomes:
measure: 28 days mortality
timeFrame: 28days after ICU admission
Secondary outcomes:
measure: ICU free days at 28 days
timeFrame: 28 days after ICU admission
measure: Hospital free days at 28 days
timeFrame: 28 days
measure: Ventilator free days at 28 days
timeFrame: 28 days at ICU admission
measure: Renal replacement therapy free days at 28 days
timeFrame: 28 days at ICU admission
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: The Japanese Society of Intensive Care Medicine
state: Tokyo
city: Songpa-gu
country: Korea, Republic of
facility: Korean Society of Critical Care Medicine
state: Seoul
Study officials:
affiliation: Korean Society of Critical Care Medicine
name: Younsuck Koh, M.D. PhD
role: STUDY_CHAIR
affiliation: Japanese Society of Intensive Care Medicine
name: Masaji Nishimura, M.D. PhD
role: STUDY_CHAIR
affiliation: Korean Society of Critical Care Medicine
name: Jae Yeol Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korean Society of Critical Care Medicine
name: Gee Young Suh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Japanese Society of Intensive Care Medicine
name: Moritoki Egi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.