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The Fever and Antipyretic in Critically Illness Evaluation Study (FACE)

J

Japanese Society of Intensive Care Medicine

Status

Completed

Conditions

Fever
Hyperthermia

Treatments

Other: Antipyretic therapy

Study type

Observational

Funder types

Other

Identifiers

NCT00940654
JSICM&KSCCM FACE

Details and patient eligibility

About

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

Full 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)

Enrollment

1,426 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

1,426 participants in 2 patient groups

Patients with fever
Treatment:
Other: Antipyretic therapy
Patients without any fever

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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