FeverFACENCT00940654
The Fever and Antipyretic in Critically Illness Evaluation Study
An observational study of Fever and Hyperthermia, run by Japanese Society of Intensive Care Medicine at 2 sites in 2 countries.
Trial summary
The purpose of this multination multicenter observational study is to determine the impact of fever and antipyretic on outcomes in critically ill patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Fever, Hyperthermia
- What is being tested?
- Antipyretic therapy
- How many people
- 1,426 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult non-neurological critically ill patients required intensive care for more than 48 hour.
Who may be able to join
- Adult non-neurological critically ill patients (20 years old or older).
- ICU patients expected to require intensive care for more than 48 hour.
Who cannot join
- Patients with brain injury (suspected or proven)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Japan1 site
The Japanese Society of Intensive Care Medicine
Bunkyo-ku, Tokyo, 113-0033
South Korea1 site
Korean Society of Critical Care Medicine
Songpa-gu, Seoul, 138-736
About this study
The purpose of this multination multicenter observational study is to determine the impact of fever and antipyretic on outcomes in critically ill patients.
Read the 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)
- Conditions
- Fever, Hyperthermia
- Being tested
- Antipyretic therapy
- Keywords
- Fever, Antipyretic, Infection, Mortality, Cooling, Non steroid anti inflammatory drugs, Acetaminophen, Steroid, ICU, Intensive care, Critically ill
- Medical subject headings
- Fever, Hyperthermia, Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipyretic therapyOther
Also called External cooling, Internal cooling, Non steroid anti inflammatory drugs, Acetaminophen
External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid
| Study group | Role | What they receive |
|---|---|---|
| Patients with fever | Not described Receives: Other: Antipyretic therapy | |
| Patients without any fever | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days mortality
Measured: 28days after ICU admission
Secondary outcomes (4)
ICU free days at 28 days
Measured: 28 days after ICU admission
Hospital free days at 28 days
Measured: 28 days
Ventilator free days at 28 days
Measured: 28 days at ICU admission
Renal replacement therapy free days at 28 days
Measured: 28 days at ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japanese Society of Intensive Care Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Younsuck Koh, M.D. PhD, Study chair, Korean Society of Critical Care MedicineMasaji Nishimura, M.D. PhD, Study chair, Japanese Society of Intensive Care MedicineJae Yeol Kim, M.D., Principal investigator, Korean Society of Critical Care MedicineGee Young Suh, M.D., Principal investigator, Korean Society of Critical Care MedicineMoritoki Egi, M.D., Principal investigator, Japanese Society of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940654
- Sponsor's protocol ID
- JSICM&KSCCM FACE
- Acronym
- FACE
- Status last verified
- Sep 2009
- First submitted
- 15 Jul 2009
- Last updated
- 19 May 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1186/cc11211.
PubMed 22373120
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fever and Antipyretic in Critically Illness Evaluation Study
- ClinicalTrials.gov ID
- NCT00940654
- Acronym / sponsor ID
- FACE / JSICM&KSCCM FACE
- Conditions
- Fever, Hyperthermia
- Keywords
- Fever, Antipyretic, Infection, Mortality, Cooling, Non steroid anti inflammatory drugs, Acetaminophen, Steroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,426 participants (actual)
- Lead sponsor
- Japanese Society of Intensive Care MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fever | – | Other: Antipyretic therapy |
| Patients without any fever | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult non-neurological critically ill patients required intensive care for more than 48 hour.
Key inclusion criteria (2 listed)
- Adult non-neurological critically ill patients (20 years old or older).
- ICU patients expected to require intensive care for more than 48 hour.
Key exclusion criteria (1 listed)
- Patients with brain injury (suspected or proven)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antipyretic therapyAlso: External cooling, Internal cooling, Non steroid anti inflammatory drugs, AcetaminophenExternal cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid | Other | Patients with fever |
Primary outcome
28 days mortality
Time frame: 28days after ICU admission
4 secondary outcomes
ICU free days at 28 days
Time frame: 28 days after ICU admission
Hospital free days at 28 days
Time frame: 28 days
Ventilator free days at 28 days
Time frame: 28 days at ICU admission
Renal replacement therapy free days at 28 days
Time frame: 28 days at ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
- Derived from this study: PubMed 22373120Lee 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. doi: 10.1186/cc11211.
- JSICMLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Younsuck Koh, M.D. PhD study chair
Korean Society of Critical Care Medicine
Masaji Nishimura, M.D. PhD study chair
Japanese Society of Intensive Care Medicine
Jae Yeol Kim, M.D. principal investigator
Korean Society of Critical Care Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Hyperthermia, run by Japanese Society of Intensive Care Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days mortality (time frame: 28days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2010.