UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040688 |
|---|---|
| Receipt number | 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 13:35:35 |
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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
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
kondokondou2000@yahoo.co.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046378
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
