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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034703
Receipt No. R000039289
Scientific Title The efficacy and safety of acetaminophen with fever in intensive care units(ICU) patients: a systematic review and meta-analysis
Date of disclosure of the study information 2018/10/30
Last modified on 2018/10/30

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Basic information
Public title The efficacy and safety of acetaminophen with fever in intensive care units(ICU) patients: a systematic review and meta-analysis
Acronym The efficacy and safety of acetaminophen with fever in intensive care units(ICU) patients
Scientific Title The efficacy and safety of acetaminophen with fever in intensive care units(ICU) patients: a systematic review and meta-analysis
Scientific Title:Acronym The efficacy and safety of acetaminophen with fever in intensive care units(ICU) patients
Region
Japan

Condition
Condition critically ill patients
Classification by specialty
Medicine in general Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fever is one of the most common symptoms regardless of outpatients or resident patients. When fever causes serious exhaustion for patients, antipyretic therapy using acetaminophen is commonly performed. There are several reports on the safety and effectiveness of antipyretic therapy with acetaminophen. However, it has been reported that administration of acetaminophen caused transient hypotension in about 50% of patients treated within intensive care unit (ICU). It has been reported that some treatment such as crystalloid infusion or increasing in vasopressor dose was necessary in about 30% of acetaminophen-induced hypotension. This supposes that administration of acetaminophen may affect the prognosis of severe ICU patients.
Paul Young et al recently reported that the number of ICU-free days to 28 day and 90-day mortality rate did not differ significantly between patients with suspected infection administered either acetaminophen or placebo. However, the influence of acetaminophen on hemodynamics has not studied in this trial. In the past report the trial itself has been discontinued because the early death has risen due to anti-pyretic therapy. It is necessary to do systematic review to disclose whether the administration of acetaminophen makes any influence on the patient's prognosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mortality at day 28
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
16 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria ICU patients
Key exclusion criteria none
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Kasai
Organization Aomori Prefectural Central Hospital
Division name Department of general medicine
Zip code
Address 2-1-1, Higashitsukurimichi, Aomori-shi, Aomori, Japan
TEL 017-726-8299
Email to_kasai@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name SHUNSUKE SOMA
Organization Aomori Prefectural Central Hospital
Division name Department of general medicine
Zip code
Address 2-1-1, Higashitsukurimichi, Aomori-shi, Aomori, Japan
TEL 017-726-8299
Homepage URL
Email shuns0114@gmail.com

Sponsor
Institute Aomori Prefectural Central Hospital
Institute
Department

Funding Source
Organization None
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
Email

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
2018 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <primary outcome>
1.mortality at day 28
2.mortality at day 90
3.ICU-free days

<secondary outcome>
1.the incidence of hypotension after injection of acetaminophen
2.therapeutic intervention at hypotension
3.quality of life(when leaving ICU)

<subgroup analysis>
1.age(over 65 years),body(under body mass index 18)
2.dose of acetaminophen(over 1000 mg)

<sensibility analysis>
we perform the following sensibility analysis on primary outcome
1.Exclusion of non-double blind studies.
2.Exclusion of studies using imputed statistics.
3.Missing participants:
Best-best scenario: all missing patients in the two groups remain unchanged
Best-worst scenario: all missing patients in the intervention group remain unchanged and all missing patients in the control group have outcomes
Worst-best scenario: all missing patients in the intervention group have outcomes and all missing patients in the control group remain unchanged
*primary analysis(worst-worst scenario: all missing patients in the two groups have outcomes)

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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