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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046157
Receipt No. R000052676
Scientific Title A retrospective study on perioperative dialysis of TAVI and AVR in patients receiving maintenance hemodialysis with severe aortic valve stenosis.
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/24

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Basic information
Public title A retrospective study on perioperative dialysis of TAVI and AVR in patients receiving maintenance hemodialysis with severe aortic valve stenosis.
Acronym A retrospective study on perioperative dialysis of TAVI and AVR in patients receiving maintenance hemodialysis with severe aortic valve stenosis.
Scientific Title A retrospective study on perioperative dialysis of TAVI and AVR in patients receiving maintenance hemodialysis with severe aortic valve stenosis.
Scientific Title:Acronym A retrospective study on perioperative dialysis of TAVI and AVR in patients receiving maintenance hemodialysis with severe aortic valve stenosis.
Region
Japan

Condition
Condition Aortic valve stenosis.
End-stage kidney disease.
Classification by specialty
Medicine in general Cardiology Nephrology
Surgery in general Vascular surgery Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The indication for Transcatheter Aortic Valve Implantation (TAVI) for maintenance hemodialysis patients with severe aortic stenosis has been expanded since January 2021, and the surgeries are being performed in facilities nationwide. There have been several studies on the prognosis and complications of TAVI in maintenance hemodialysis patients, but there have been no studies on perioperative dialysis stability and adverse events during dialysis. Therefore, we will compare the perioperative stability, adverse events, prognosis, and complications of TAVI or aortic valve replacement (AVR) in maintenance hemodialysis patients with severe aortic stenosis at our hospital.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Hypotension in dialysis during the perioperative period.
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 We enrolled maintenance hemodialysis patients who were diagnosed with severe aortic stenosis and underwent TAVI or AVR among those who visited our hospital from April 2013 to December 2021.
Key exclusion criteria Patients who were not on maintenance hemodialysis preoperatively, or who had undergone coronary artery bypass grafting (CABG), valvular surgery other than aortic valve surgery, or major vascular surgery as simultaneous operations were excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshihiko
Middle name
Last name Suzuki
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Department of Nephrology, Endocrinology and Diabetes
Zip code 2790001
Address 3-4-32, Todaijima, Urayasu, Chiba
TEL +81-47-351-3101
Email suzutoshibay@gmail.com

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Sakai
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Department of Nephrology, Endocrinology and Diabetes
Zip code 2790001
Address 3-4-32, Todaijima, Urayasu, Chiba
TEL +81-47-351-3101
Homepage URL
Email masahirosa@jadecom.jp

Sponsor
Institute Department of Nephrology, Endocrinology and Diabetes, Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization None
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 Tokyo Bay Urayasu Ichikawa Medical Center
Address 3-4-32, Todaijima, Urayasu, Chiba
Tel +81-47-351-3101
Email masahirosa@jadecom.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
2021 Year 12 Month 01 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
2021 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study

Management information
Registered date
2021 Year 11 Month 24 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052676

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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