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

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ClinicalTrials.gov Identifier: NCT00940654
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : May 19, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Fever Hyperthermia Other: Antipyretic therapy

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 Type : Observational
Actual Enrollment : 1426 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Fever and Antipyretic in Critically Illness Evaluation Study
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with fever Other: Antipyretic therapy
External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid
Other Names:
  • External cooling
  • Internal cooling
  • Non steroid anti inflammatory drugs
  • Acetaminophen
  • Steroid
  • Others
Patients without any fever



Primary Outcome Measures :
  1. 28 days mortality [ Time Frame: 28days after ICU admission ]

Secondary Outcome Measures :
  1. ICU free days at 28 days [ Time Frame: 28 days after ICU admission ]
  2. Hospital free days at 28 days [ Time Frame: 28 days ]
  3. Ventilator free days at 28 days [ Time Frame: 28 days at ICU admission ]
  4. Renal replacement therapy free days at 28 days [ Time Frame: 28 days at ICU admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult non-neurological critically ill patients required intensive care for more than 48 hour.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940654


Locations
Japan
The Japanese Society of Intensive Care Medicine
Bunkyo-ku, Tokyo, Japan, 113-0033
Korea, Republic of
Korean Society of Critical Care Medicine
Songpa-gu, Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Japanese Society of Intensive Care Medicine
Investigators
Study Chair: Younsuck Koh, M.D. PhD Korean Society of Critical Care Medicine
Study Chair: Masaji Nishimura, M.D. PhD Japanese Society of Intensive Care Medicine
Principal Investigator: Jae Yeol Kim, M.D. Korean Society of Critical Care Medicine
Principal Investigator: Gee Young Suh, M.D. Korean Society of Critical Care Medicine
Principal Investigator: Moritoki Egi, M.D. Japanese Society of Intensive Care Medicine

Additional Information:
JSICM  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Japanese Society of Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00940654     History of Changes
Other Study ID Numbers: JSICM&KSCCM FACE
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: September 2009

Keywords provided by Japanese Society of Intensive Care Medicine:
Fever
Antipyretic
Infection
Mortality
Cooling
Non steroid anti inflammatory drugs
Acetaminophen
Steroid
ICU
Intensive care
Critically ill

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Antipyretics
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs