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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040688
Receipt No. R000046378
Scientific Title Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Date of disclosure of the study information 2020/06/08
Last modified on 2020/06/08

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Basic information
Public title Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Acronym Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Scientific Title Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Scientific Title:Acronym Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Region
Japan

Condition
Condition Sepsis or septic shock
Classification by specialty
Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to conduct systematic review and meta-analysis of the present randomized controlled trials (RCTs) to assess the efficacy of prolonged versus intermittent beta-lactam antibiotics infusion strategy on outcomes in sepsis or septic shock patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hospital mortality
Key secondary outcomes attainment of target plasma concentration, clinical cure, adverse event, and occurrence of antibiotic-resistant bacteria

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 We identified studies to be included by following the research question formulated according to the participants, interventions, comparisons and outcomes (PICO) model as follows: P, adult (>=18 years of age) patients admitted to the ICU with a diagnosis of sepsis or septic shock; I, prolonged beta-lactam antibiotics infusion strategy (continuous or extended time [more than 1 hour but not continuous] of intravenous infusion); C, intermittent beta-lactam antibiotics infusion strategy (within 1 hour of intravenous infusion); O, All-cause mortality.
Key exclusion criteria Under 18 years-old
Target sample size

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Kondo
Organization Juntendo University Urayasu Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code 279-0021
Address 2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL 047-353-3111
Email kondokondou2000@yahoo.co.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Kondo
Organization Juntendo University Urayasu Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code 279-0021
Address 2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL 047-353-3111
Homepage URL
Email kondokondou2000@yahoo.co.jp

Sponsor
Institute Juntendo University Urayasu Hospital
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 Juntendo University Urayasu Hospital
Address Department of Emergency and Critical Care Medicine
Tel 047-353-3111
Email kondokondou2000@yahoo.co.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 06 Month 08 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 825
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
2019 Year 04 Month 27 Day
Date of IRB
2019 Year 04 Month 27 Day
Anticipated trial start date
2019 Year 04 Month 27 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <Search method>
Electronic detabases were used below.
1. the Cochrane Central Register of Controlled Trials(CENTRAL)
2. MEDLINE
3. Igaku Chuo Zasshi (ICHUSHI) Web

<Analysis>
Meta-analysis will be performed using the Review Manger, Cochrane systematic review software, version 5.3.5 for Windows.

Management information
Registered date
2020 Year 06 Month 08 Day
Last modified on
2020 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046378

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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