The Fever and Antipyretic in Critically Illness Evaluation Study (FACE)
| Tracking Information | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 15, 2009 | ||||||||||||||||||||
| Last Updated Date | May 18, 2010 | ||||||||||||||||||||
| Start Date ICMJE | September 2009 | ||||||||||||||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
28 days mortality [ Time Frame: 28days after ICU admission ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00940654 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | The Fever and Antipyretic in Critically Illness Evaluation Study | ||||||||||||||||||||
| Official Title ICMJE | The Fever and Antipyretic in Critically Illness Evaluation Study | ||||||||||||||||||||
| 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) |
||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||
| Sampling Method | Probability Sample | ||||||||||||||||||||
| Study Population | Adult non-neurological critically ill patients required intensive care for more than 48 hour. |
||||||||||||||||||||
| Condition ICMJE |
|
||||||||||||||||||||
| Intervention ICMJE | Other: Antipyretic therapy
External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid
Other Names:
|
||||||||||||||||||||
| Study Group/Cohort (s) |
|
||||||||||||||||||||
| Publications * | Lee BH, Inui D, Suh GY, Kim JY, Kwon JY, Park J, Tada K, Tanaka K, Ietsugu K, Uehara K, Dote K, Tajimi K, Morita K, Matsuo K, Hoshino K, Hosokawa K, Lee KH, Lee KM, Takatori M, Nishimura M, Sanui M, Ito M, Egi M, Honda N, Okayama N, Shime N, Tsuruta R, Nogami S, Yoon SH, Fujitani S, Koh SO, Takeda S, Saito S, Hong SJ, Yamamoto T, Yokoyama T, Yamaguchi T, Nishiyama T, Igarashi T, Kakihana Y, Koh Y; Fever and Antipyretic in Critically ill patients Evaluation (FACE) Study Group. Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study. Crit Care. 2012 Feb 28;16(1):R33. | ||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | 1426 | ||||||||||||||||||||
| Completion Date | December 2009 | ||||||||||||||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||
| Ages | 20 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Japan, Korea, Republic of | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT00940654 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | JSICM&KSCCM FACE | ||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||
| Responsible Party | Japanese Society of Intensive Care Medicine | ||||||||||||||||||||
| Study Sponsor ICMJE | Japanese Society of Intensive Care Medicine | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||
| Information Provided By | Japanese Society of Intensive Care Medicine | ||||||||||||||||||||
| Verification Date | September 2009 | ||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||