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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Sepsis or septic shock | |||
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |