UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040174
Receipt No. R000045746
Scientific Title The effect of esmolol and landiolol on the mortality in patients with sepsis and septic shock with tachycardia: A systematic review and meta-analysis of randomized controlled trials
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of esmolol and landiolol on the mortality in patients with sepsis and septic shock with tachycardia: A systematic review and meta-analysis of randomized controlled trials
Acronym The effect of esmolol and landiolol on the mortality in patients with sepsis and septic shock with tachycardia: A systematic review and meta-analysis of randomized controlled trials
Scientific Title The effect of esmolol and landiolol on the mortality in patients with sepsis and septic shock with tachycardia: A systematic review and meta-analysis of randomized controlled trials
Scientific Title:Acronym The effect of esmolol and landiolol on the mortality in patients with sepsis and septic shock with tachycardia: A systematic review and meta-analysis of randomized controlled trials
Region
Japan North America

Condition
Condition Sepsis and septic shock
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of esmolol an landiolol on morality and to elucidate the occurrence of its complication for the patients with sepsis and septic shock
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Short term mortality (in hospital mortality, 28 day mortality)
Key secondary outcomes White blood cell count, troponin I, BNP, inflammatory marker and so forth
Hemodynamic status(heart rate, blood pressure and so on)

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Study types: randomized controlled trial (RCT).
2. Population: Patients no less than 18 years old and with sepsis based on any one of sepsis-1, sepsis-2, or sepsis-3 definitions.
3. Intervention: Intravenous esmolol or landiolol administration at any dose.
4. Control: Placebo or no intervention (without esmolol or landiolol administration).
Key exclusion criteria studies not met inclusion criteria
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Hasegawa
Organization Fujita Health University School of Medicine
Division name Anesthesiology and critical care medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL 0562-93-9008
Email dhsgw@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Hasegawa
Organization Fujita Health University School of Medicine
Division name Anesthesiology and critical care medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL 0562-93-9008
Homepage URL
Email dhsgw@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Anesthesiology and critical care medicine
Institute
Department

Funding Source
Organization No funding
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 Fujita Health University School of Medicine
Address 1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel 0562-93-9008
Email dhsgw@fujita-hu.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 05 Month 01 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 04 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 15 Day
Last follow-up date
2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A comprehensive search of three major databases of biomedical publications will be performed on 20 April 2020: MEDLINE (source: PubMed, 1966 to April 2020), Cochrane Central Register of Controlled Trials (through April 2020), Embase (1974 to April 2020) with the following keywords in each query: esmolol, landiolol, Adrenergic beta-Antagonists, sepsis, Systemic inflammatory response syndrome, and Multiple Organ Failure.
The search terms used were:(((((((((((Adrenergic beta-Antagonists[Mesh]) OR Adrenergic beta-Antagonist[Title/Abstract]) OR beta blocker[Title/Abstract]) OR beta antagonist[Title/Abstract]) OR landiolol[Title/Abstract]) OR esmolol[Title/Abstract]) AND ((Sepsis[mesh] OR Sepsis[tiab] OR Systemic inflammatory response syndrome[mesh] OR Systemic inflammatory response syndrome[tiab] OR SIRS[tiab] OR Multiple Organ Failure[mesh] OR Multiple Organ Failure[tiab] OR MOF[tiab])))).
Two independent reviewers will screen the abstracts and titles of the studies and subsequently review the full-text articles for inclusion on the Rayyan. if necessary. We will use Google Translate for articles that are not published in English to minimize the selection bias.
Independent reviewers will assess the risk of bias in each trial as the methodological quality of the articles. Disagreements will be resolved by discussion, consensus and the participation of a third author, when necessary.

Management information
Registered date
2020 Year 04 Month 15 Day
Last modified on
2020 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045746

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.