The Fever and Antipyretic in Critically Illness Evaluation Study

Completed

• Conditions: Hyperthermia; Fever
• Interventions: Other: Antipyretic therapy

• Registration Number: NCT00940654
• Lead Sponsor: Japanese Society of Intensive Care Medicine

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)

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Status Verified: 2009-09
• Study Start: 2009-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2010-05-18
• Last Update Posted: 2010-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1426

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with fever	Antipyretic therapy	-

Primary Outcome Measures

Name	Time	Method
28 days mortality	28days after ICU admission

Secondary Outcome Measures

Name	Time	Method
ICU free days at 28 days	28 days after ICU admission
Hospital free days at 28 days	28 days
Renal replacement therapy free days at 28 days	28 days at ICU admission
Ventilator free days at 28 days	28 days at ICU admission

Trial Locations

Locations (2)

The Japanese Society of Intensive Care Medicine; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Korean Society of Critical Care Medicine; 🇰🇷 Songpa-gu, Seoul, Korea, Republic of