UMIN-CTR Clinical Trial

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
Email	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
Email	kohji.fentanyl@gmail.com

Sponsor
Institute	Kyorin University Hospital Department of Anesthesiology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043550