UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005593 |
|---|---|
| Receipt number | R000006527 |
| Scientific Title | Fever and Antipyretic in Critically ill Evaluation :phase II randomized controlled trial (FACE II trial) |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/05/14 16:48:01 |
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Basic information
Public title
Fever and Antipyretic in Critically ill Evaluation :phase II randomized controlled trial (FACE II trial)
Acronym
Fever and Antipyretic in Critically ill Evaluation :phase II randomized controlled trial
Scientific Title
Fever and Antipyretic in Critically ill Evaluation :phase II randomized controlled trial (FACE II trial)
Scientific Title:Acronym
Fever and Antipyretic in Critically ill Evaluation :phase II randomized controlled trial
Region
| Asia(except Japan) |
Condition
Condition
All patients admitted to intensive care with a temperature higher than 38.0 degrees C for study enrolment.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim is to compare the effects of two temperature targets on ICU-free survival at 28 days in non-neurologically-injured patients requiring emergency intensive care admission who have a temperature of hier than 38.0 degres C at any time during their ICU admission. The null hypothesis is that there is no difference in ICU-free survival at day 28 in those patients assigned a temperature target of < 38 degrees C and those assigned a temperature target of < 39.6 degrees C.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The principal study outcome will be whether the number of 'alive ICU-free days' measured at day 28. This outcome will be determined by the research coordinator at each participating centre. The study monitor will verify the source documentation at each monitoring visit. Alive ICU-free days is a robust outcome, and although unintended bias in outcome assessment is unlikely, this will be refined by the secondary endpoint of 'need for intensive care support'.
Key secondary outcomes
Time without requirement for any of the following:
1. vasoactive agent
2. renal replacement therapy
3. invasive or non-invasive positive pressure ventilation
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the intensive strategy, at study entry, any antipyretics (physical cooling or medications) should be prescribed if the patient's core temperature is equal or greater than 38.0. Antipyretic will be stopped when core temperature is less than 37.5.
Interventions/Control_2
In the permissive strategy, any antipyretics (physical cooling or medications) may be considered for use, at the discretion of the treating clinician, if the patient's core temperature is equal or greater than 39.5. Antipyretic will be stopped when core temperature is less than 39.0.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are eligible to be included in the study if:
1.= or >20 years old
2.Patients who expected to still be ICU the day after tomorrow of randomization.
3.Patients who expected NOT to have a requirement for an analgesic regimen containing paracetamol, NSAIDs or COX-2 inhibitors within the next 3 days.
4.Patients in which body temperature (esophageal, bladder, renal, blood, tympanic membrane or axillary temperature) can be measured at least every four hourly.
5.Documented core temperature greter than 38.0 degree of Celsius in ICU (if tympanic & axillary, > 37.5 degree of Celsius)
Key exclusion criteria
1.Acute brain injury defined as acute traumatic brain injury, subarachnoid haemorrhage, acute ischaemic stroke, acute intracerebral haemorrhage, acute intracranial infection or cardiac arrest
2.The treating clinician expects the patient to have a requirement for an analgaesic regimen containing paracetamol, NSAIDs or COX-2 inhibitors within the next 3 days.
3.Diagnosis of heat stroke, or, malignant hyperthermia, neuroleptic malignant syndrome, or other drug-induced hyperthermia, rhabdomyolysis, and thyrotoxicosis
4.Pregnancy
5.Imminent death (cardiac standstill or brain death anticipated in less than 24 hours) and the treating clinicians are not committed to full supportive care.
Target sample size
310
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaji Nishimura |
Organization
The Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
Address
2-50-1 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-9425
nmasaji@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | IRB |
Organization
The Tokushima University Hospital
Division name
IRB
Zip code
Address
2-50-1 Kuramoto, Tokushima
TEL
088-633-9294
Homepage URL
first-ec@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
The Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Emergency and Critical Care Medicine, The Tokushima University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 12 | Day |
Last modified on
| 2014 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006527
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
