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The Fever and Antipyretic in Critically Illness Evaluation Study

The Fever and Antipyretic in Critically Illness Evaluation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00940654
Acronym
FACE
Enrollment
1426
Registered
2009-07-16
Start date
2009-09-30
Completion date
2009-12-31
Last updated
2010-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Hyperthermia

Keywords

Fever, Antipyretic, Infection, Mortality, Cooling, Non steroid anti inflammatory drugs, Acetaminophen, Steroid, ICU, Intensive care, Critically ill

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)

Interventions

OTHERAntipyretic therapy

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

Sponsors

Japanese Society of Intensive Care Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
28 days mortality28days after ICU admission

Secondary

MeasureTime frame
ICU free days at 28 days28 days after ICU admission
Hospital free days at 28 days28 days
Ventilator free days at 28 days28 days at ICU admission
Renal replacement therapy free days at 28 days28 days at ICU admission

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026