UMIN-CTR Clinical Trial

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

critically ill patients

Classification by specialty

Medicine in general

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

mortality at day 28

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Aomori Prefectural Central Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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)

Registered date

2018

Year

10

Month

30

Day

Last modified on

2019

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039289