The Fever and Antipyretic in Critically Illness Evaluation Study

Fever Clinical Trial

— FACE  

Official title:

The Fever and Antipyretic in Critically Illness Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940654
• Other study ID #: JSICM&KSCCM FACE
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: May 18, 2010
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Japanese Society of Intensive Care Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1426
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fever
• Hyperthermia

Intervention

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

Locations

Country	Name	City	State
Japan	The Japanese Society of Intensive Care Medicine	Bunkyo-ku	Tokyo
Korea, Republic of	Korean Society of Critical Care Medicine	Songpa-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Japanese Society of Intensive Care Medicine

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days mortality		28days after ICU admission	No
Secondary	ICU free days at 28 days		28 days after ICU admission	No
Secondary	Hospital free days at 28 days		28 days	No
Secondary	Ventilator free days at 28 days		28 days at ICU admission	No
Secondary	Renal replacement therapy free days at 28 days		28 days at ICU admission	No

External Links

•   JSICM