UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052979 |
|---|---|
| Receipt number | R000060365 |
| Scientific Title | Prophylactic use of glucocorticoids to reduce postoperative delirium in adult patients: A systematic review with meta-analysis |
| Date of disclosure of the study information | 2023/12/10 |
| Last modified on | 2023/12/09 09:10:12 |
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Basic information
Public title
Prophylactic use of glucocorticoids to reduce postoperative delirium in adult patients: A systematic review with meta-analysis
Acronym
Prophylactic use of glucocorticoids to reduce postoperative delirium in adult patients: A systematic review with meta-analysis
Scientific Title
Prophylactic use of glucocorticoids to reduce postoperative delirium in adult patients: A systematic review with meta-analysis
Scientific Title:Acronym
Prophylactic use of glucocorticoids to reduce postoperative delirium in adult patients: A systematic review with meta-analysis
Region
| Japan |
Condition
Condition
Adult patients who underwent surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted this updated systematic review and meta-analysis of RCTs to explore the effect of prophylactic use of glucocorticoids on the incidence of postoperative delirium (POD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of POD
Key secondary outcomes
Incidence of postoperative infection, respiratory failure, and 30 day-mortality.
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
Adult patients underwent surgery
Key exclusion criteria
Pediatric surgical patients
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Maruyama |
Organization
Teikyo University School of Medicine, Mizonokuchi Hospital
Division name
Department of anesthesiology
Zip code
213-8507
Address
5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan
TEL
0448443333
kmaruyam@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Maruyama |
Organization
Teikyo University School of Medicine, Mizonokuchi Hospital
Division name
Department of anesthesiology
Zip code
213-8507
Address
5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan
TEL
0448443333
Homepage URL
kmaruyam@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine, Mizonokuchi Hospital
Institute
Department
Personal name
Koichi Maruyama
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2023 | Year | 12 | Month | 10 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We searched these electric databases; PubMed search engine, Cochrane Central Register of Controlled Trials (CENTRAL), SCOPUS, and Web of Science. Studies investigating POD in the adult patients were included. The primary outcome of this meta-analysis was the incidence of POD. The secondary outcomes were, postoperative infection, respiratory failure, and 30 day-mortality. We combined data using a random-effect model (Der Simonian-Laird method). When significant heterogeneity was defined as an I2 statistic exceeded 40%, the preplanned subgroup analyze was performed according to type of surgery (cardiac vs noncardiac) to determine if the source of heterogeneity could be explained. To test the robustness of the results, preplanned sensitivity analysis was performed excluding studies of high risk of bias and some concerns. Additionally, the number need to treat was used to evaluate the impact of effect with intervention. The RCTs were assessed using risk of bias assessment, and quality of evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
Management information
Registered date
| 2023 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060365
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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