UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038933 |
|---|---|
| Receipt number | R000044398 |
| Scientific Title | Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI |
| Date of disclosure of the study information | 2019/12/19 |
| Last modified on | 2021/06/16 14:42:00 |
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Basic information
Public title
Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Acronym
Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Scientific Title
Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Scientific Title:Acronym
Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Region
| Japan |
Condition
Condition
abnormal hypertension before elective surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The development of postoperative acute kidney injury (AKI) is associated with worse outcomes. Therefore, it is important to identify the incidence and risk factors of postoperative AKI. Chronic hypertension has been reported as a risk factor for postoperative AKI. On the other hand, uncontrolled hypertension before the induction of anesthesia is often encountered, but there is no report showing the relationship between this hypertension and postoperative AKI.
The purpose of this study is to investigate the relation between uncontrolled hypertension before the induction of anesthesia and incidence of postoperative AKI and to identify perioperative risk factors of that.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is occurrence of postoperative AKI by the KDIGO criteria.
Key secondary outcomes
Secondary outcome is preoperative and intraoperative risk factors of postoperative AKI.
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
| 150 | years-old | > |
Gender
Male and Female
Key inclusion criteria
elective surgery patients with severe hypertansion
Key exclusion criteria
emergency surgery
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
maiko.satomoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
maiko.satomoto@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Toho University School of Medicine, Department of Anesthesiology
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
Toho University Ethics Review Board
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
Tel
0337624151
omori.rinri@ext.toho-u.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
| 2019 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
DOI: 10.14994/tohojmed.2020-018
Publication of results
Unpublished
Result
URL related to results and publications
DOI: 10.14994/tohojmed.2020-018
Number of participants that the trial has enrolled
274
Results
DOI: 10.14994/tohojmed.2020-018
Results date posted
| 2021 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
DOI: 10.14994/tohojmed.2020-018
Participant flow
DOI: 10.14994/tohojmed.2020-018
Adverse events
DOI: 10.14994/tohojmed.2020-018
Outcome measures
DOI: 10.14994/tohojmed.2020-018
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observation study
Management information
Registered date
| 2019 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044398
