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

This study has been completed.
Sponsor:
Information provided by:
Japanese Society of Intensive Care Medicine
ClinicalTrials.gov Identifier:
NCT00940654
First received: July 15, 2009
Last updated: May 18, 2010
Last verified: September 2009

July 15, 2009
May 18, 2010
September 2009
December 2009   (final data collection date for primary outcome measure)
28 days mortality [ Time Frame: 28days after ICU admission ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940654 on ClinicalTrials.gov Archive Site
  • ICU free days at 28 days [ Time Frame: 28 days after ICU admission ] [ Designated as safety issue: No ]
  • Hospital free days at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Ventilator free days at 28 days [ Time Frame: 28 days at ICU admission ] [ Designated as safety issue: No ]
  • Renal replacement therapy free days at 28 days [ Time Frame: 28 days at ICU admission ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Fever and Antipyretic in Critically Illness Evaluation Study
The Fever and Antipyretic in Critically Illness Evaluation Study

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

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)

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Fever
  • Hyperthermia
Other: Antipyretic therapy
External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid
Other Names:
  • External cooling
  • Internal cooling
  • Non steroid anti inflammatory drugs
  • Acetaminophen
  • Steroid
  • Others
  • Patients with fever
    Intervention: Other: Antipyretic therapy
  • Patients without any fever
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1426
December 2009
December 2009   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of
 
NCT00940654
JSICM&KSCCM FACE
No
Japanese Society of Intensive Care Medicine
Japanese Society of Intensive Care Medicine
Not Provided
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
Japanese Society of Intensive Care Medicine
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP