UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048745 |
|---|---|
| Receipt number | R000055528 |
| Scientific Title | The effects of residual kidney function on hemodynamic changes of patients on hemodialysis in general anesthesia induction: a retrospective observational study |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2024/02/03 10:36:30 |
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Basic information
Public title
The effects of residual kidney function on hemodynamic changes of patients on hemodialysis in general anesthesia induction: a retrospective observational study
Acronym
The effects of residual kidney function on hemodynamic changes of patients on hemodialysis in general anesthesia induction: a retrospective observational study
Scientific Title
The effects of residual kidney function on hemodynamic changes of patients on hemodialysis in general anesthesia induction: a retrospective observational study
Scientific Title:Acronym
The effects of residual kidney function on hemodynamic changes of patients on hemodialysis in general anesthesia induction: a retrospective observational study
Region
| Japan |
Condition
Condition
Patients on hemodialysis who undergo a scheduled operation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether residual kidney function of patients on hemodialysis has an effect on hemodynamic changes during general anesthesia induction.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the severity of hypotension during general anesthesia
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on hemodialysis who underwent a scheduled operation
Key exclusion criteria
Patients who underwent renal transplantation
Target sample size
766
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Hino |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
TEL
0666452186
HinoH@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hino |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
TEL
0666452186
Homepage URL
HinoH@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University Graduate School of Medicine, Department of Anesthesiology
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
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
Tel
0666453456
gr-a-knky-ethics@omu.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
| 2022 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.micenavi.jp/jsa70/search/result_list_multiple
Publication of results
Partially published
Result
URL related to results and publications
https://www.micenavi.jp/jsa70/search/result_list_multiple
Number of participants that the trial has enrolled
1086
Results
The main results were presented at the 70th Annual Meeting of the Japanese Society of Anesthesiologists (Kobe, 2023).
Results date posted
| 2024 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients on hemodialysis who underwent surgeries under general anesthesia
Participant flow
The main results were presented at the 70th Annual Meeting of the Japanese Society of Anesthesiologists (Kobe, 2023).
Adverse events
None
Outcome measures
Blood pressure decreases after the induction of general anesthesia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate whether residual kidney functions of patients on hemodialysis have hemodynamic effects in general anesthesia induction.
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055528
| 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 |
