UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040174 |
|---|---|
| Receipt number | 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 | 2021/04/14 00:37:53 |
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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
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
dhsgw@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Anesthesiology and critical care medicine
Institute
Department
Personal name
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
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
https://journal.chestnet.org/article/S0012-3692(21)00035-0/fulltext
Publication of results
Published
Result
URL related to results and publications
https://journal.chestnet.org/article/S0012-3692(21)00035-0/fulltext
Number of participants that the trial has enrolled
613
Results
Seven RCTs with a pooled sample size of 613 patients were included. Of these, six RCTs with 572 patients reported 28-day mortality. Esmolol or landiolol use in patients with sepsis and septic shock was significantly associated with lower 28-day mortality (risk ratio, 0.68; 95% CI, 0.54-0.85; P < .001). Unimportant heterogeneity was observed (I2 = 31%). The absolute risk reduction and number of patients to be treated to prevent one death were 18.2% and 5.5, respectively.
Results date posted
| 2021 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 09 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 15 | Day |
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
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045746
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| Registered date | File name |
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