The Fever and Antipyretic in Critically Illness Evaluation Study (FACE)
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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 |
- 28 days mortality [ Time Frame: 28days after ICU admission ] [ Designated as safety issue: No ]
- 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:
|
| 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 |
Adult non-neurological critically ill patients required intensive care for more than 48 hour.
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| 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 | |
| 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:
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 Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013