The Fever and Antipyretic in Critically Illness Evaluation Study

NCT ID: NCT00940654

Last Updated: 2010-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1426 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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)

Conditions

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Fever Hyperthermia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with fever

Antipyretic therapy

Intervention Type OTHER

External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid

Patients without any fever

No interventions assigned to this group

Interventions

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Antipyretic therapy

External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid

Intervention Type OTHER

Other Intervention Names

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External cooling Internal cooling Non steroid anti inflammatory drugs Acetaminophen Steroid Others

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japanese Society of Intensive Care Medicine

OTHER

Sponsor Role lead

Responsible Party

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Japanese Society of Intensive Care Medicine

Principal Investigators

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Younsuck Koh, M.D. PhD

Role: STUDY_CHAIR

Korean Society of Critical Care Medicine

Masaji Nishimura, M.D. PhD

Role: STUDY_CHAIR

Japanese Society of Intensive Care Medicine

Jae Yeol Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Korean Society of Critical Care Medicine

Gee Young Suh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Korean Society of Critical Care Medicine

Moritoki Egi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Japanese Society of Intensive Care Medicine

Locations

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The Japanese Society of Intensive Care Medicine

Bunkyo-ku, Tokyo, Japan

Site Status

Korean Society of Critical Care Medicine

Songpa-gu, Seoul, South Korea

Site Status

Countries

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Japan South Korea

References

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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.

Reference Type DERIVED
PMID: 22373120 (View on PubMed)

Related Links

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Other Identifiers

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JSICM&KSCCM FACE

Identifier Type: -

Identifier Source: org_study_id

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