UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 10 Month 16 Day
Date of IRB	2018 Year 10 Month 20 Day
Anticipated trial start date	2018 Year 10 Month 30 Day
Last follow-up date	2018 Year 11 Month 30 Day
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	2019 Year 10 Month 31 Day

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