UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038208 |
|---|---|
| Receipt number | R000043550 |
| Scientific Title | Retrospective observational study of the postoperative prognosis of patients with pulmonary hypertension influenced by preoperative and anesthetic management |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2022/04/06 10:32:33 |
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Basic information
Public title
Retrospective observational study of the postoperative prognosis of patients with pulmonary hypertension influenced by preoperative and anesthetic management
Acronym
Retrospective observational study of the postoperative prognosis of patients with pulmonary hypertension influenced by preoperative and anesthetic management
Scientific Title
Retrospective observational study of the postoperative prognosis of patients with pulmonary hypertension influenced by preoperative and anesthetic management
Scientific Title:Acronym
Retrospective observational study of the postoperative prognosis of patients with pulmonary hypertension influenced by preoperative and anesthetic management
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the prognosis and prognostic factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative mortality
Key secondary outcomes
postoperative complications, and hospital stay
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient was diagnosed as pulmonary hypertension in Kyorin Univ. medical school affiliated hospital from April 1, 2008 to March 31, 2019, and underwent the operation.
Key exclusion criteria
Patients with pulmonary hypertension before or after cardiac surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kohji |
| Middle name | |
| Last name | Uzawa |
Organization
Kyorin University Hospital
Division name
anesthesiology
Zip code
181-0004
Address
6-20-2 Shinkawa Mitaka-shi Tokyo Japan
TEL
0422-47-5511
kohji.fentanyl@gmail.com
Public contact
Name of contact person
| 1st name | Kohji |
| Middle name | |
| Last name | Uzawa |
Organization
Kyorin University Hospital
Division name
anesthesiology
Zip code
181-0004
Address
6-20-2 Shinkawa Mitaka-shi Tokyo Japan
TEL
0422-47-5511
Homepage URL
kohji.fentanyl@gmail.com
Sponsor or person
Institute
Kyorin University Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kyorin University Hospital
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
Kyorin University Hospital department of Anesthesiology
Address
6-20-2 Shinkawa Mitaka-shi Tokyo Japan
Tel
0422-47-5511
kohji.fentanyl@gmail.com
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
杏林大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 04 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043550
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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