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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042624
Receipt No. R000048313
Scientific Title Optimal target blood pressure in critically ill adult patients with vasodilatory shock: a systematic review and meta-analysis
Date of disclosure of the study information 2020/12/02
Last modified on 2020/12/02

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Basic information
Public title Optimal target blood pressure in critically ill adult patients with vasodilatory shock: a systematic review and meta-analysis
Acronym Optimal target blood pressure in vasodilatory shock
Scientific Title Optimal target blood pressure in critically ill adult patients with vasodilatory shock: a systematic review and meta-analysis
Scientific Title:Acronym Optimal target blood pressure in vasodilatory shock
Region
Japan

Condition
Condition critically ill adult patients with vasodilatory shock
Classification by specialty
Medicine in general Infectious disease Surgery in general
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the optimal target blood pressure in critically ill adult patients with vasodilatory shock
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause mortality at 28day and 90day
Key secondary outcomes Organ dysfunction (respiratory and renal)
Serious adverse events

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

Not applicable
Gender Male and Female
Key inclusion criteria editing
Key exclusion criteria editing
Target sample size

Research contact person
Name of lead principal investigator
1st name Kazuma
Middle name
Last name Yamakawa
Organization Osaka Medical College
Division name Department of Emergency Medicine
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki, Osaka 569-8686, Japan
TEL 0726831221
Email kyamakawa-osk@umin.ac.jp

Public contact
Name of contact person
1st name Kazuma
Middle name
Last name Yamakawa
Organization Osaka Medical College
Division name Department of Emergency Medicine
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki, Osaka 569-8686, Japan
TEL 0726831221
Homepage URL
Email kyamakawa-osk@umin.ac.jp

Sponsor
Institute Department of Emergency Medicine, Osaka Medical College
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Medical College
Address 2-7 Daigakumachi, Takatsuki, Osaka 569-8686, Japan
Tel 0726831221
Email kyamakawa-osk@umin.ac.jp

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
2020 Year 12 Month 02 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
2020 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information If sufficient studies are available, we will undertake subgroup analyses to explore the sources of potential heterogeneity in sensitivity and specificity. Subgroup analysis will be performed using the following as covariates: sepsis or not, existence of chronic hypertension, age, targeted blood pressure.

Management information
Registered date
2020 Year 12 Month 02 Day
Last modified on
2020 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048313

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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