The Fever and Antipyretic in Critically Illness Evaluation Study

Study Overview
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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)

Official Title
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The Fever and Antipyretic in Critically Illness Evaluation Study

Conditions
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Hyperthermia, Fever

Intervention / Treatment
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* Other: Antipyretic therapy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with fever<br> | Other: Antipyretic therapy<br>* External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid<br>* Other names: Others;|
| Patients without any fever<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days mortality |  | 28days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU free days at 28 days |  | 28 days after ICU admission | 
| Hospital free days at 28 days |  | 28 days | 
| Ventilator free days at 28 days |  | 28 days at ICU admission | 
| Renal replacement therapy free days at 28 days |  | 28 days at ICU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever, Antipyretic, Infection, Mortality, Cooling, Non steroid anti inflammatory drugs, Acetaminophen, Steroid, ICU, Intensive care, Critically ill