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

This study has been completed.
Sponsor:
Information provided by:
Japanese Society of Intensive Care Medicine
ClinicalTrials.gov Identifier:
NCT00940654
First received: July 15, 2009
Last updated: May 18, 2010
Last verified: September 2009
  Purpose

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


Condition Intervention
Fever
Hyperthermia
Other: Antipyretic therapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Fever and Antipyretic in Critically Illness Evaluation Study

Resource links provided by NLM:


Further study details as provided by Japanese Society of Intensive Care Medicine:

Primary Outcome Measures:
  • 28 days mortality [ Time Frame: 28days after ICU admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU free days at 28 days [ Time Frame: 28 days after ICU admission ] [ Designated as safety issue: No ]
  • Hospital free days at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Ventilator free days at 28 days [ Time Frame: 28 days at ICU admission ] [ Designated as safety issue: No ]
  • Renal replacement therapy free days at 28 days [ Time Frame: 28 days at ICU admission ] [ Designated as safety issue: No ]

Enrollment: 1426
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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

No publications provided by Japanese Society of Intensive Care Medicine

Additional 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
Study First Received: July 15, 2009
Last Updated: May 18, 2010
Health Authority: Japan: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014