UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054658 |
|---|---|
| Receipt number | R000062458 |
| Scientific Title | Risk factors for reperfusion ventricular fibrillation immediately after cardio-pulmonary bypass |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/13 17:45:34 |
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Basic information
Public title
Risk factors for reperfusion ventricular fibrillation immediately after cardio-pulmonary bypass
Acronym
Risk factors for reperfusion ventricular fibrillation immediately after cardio-pulmonary bypass
Scientific Title
Risk factors for reperfusion ventricular fibrillation immediately after cardio-pulmonary bypass
Scientific Title:Acronym
Risk factors for reperfusion ventricular fibrillation immediately after cardio-pulmonary bypass
Region
| Japan |
Condition
Condition
Cardiovascular surgery under cardio-pulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore risk factors and develop a prediction model for reperfusion ventricular fibrillation by using the University of Tsukuba Hospital perioperative dataset.
Basic objectives2
Others
Basic objectives -Others
To explore risk factors and develop a prediction model
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative use and frequency of electrical cardioversion for cardiac surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent cardiac surgery using cardio-pulmonary bypass with aortic clamping at the University of Tsukuba Hospital from April 1, 2012 to March 31, 2023.
Key exclusion criteria
Children. Patients with errors or deficiencies in key data.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Tamiya |
Organization
University of Tsukuba
Division name
Department of Health Services Research, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tenno-dai, Tsukuba, Ibaraki, Japan
TEL
+81-(0)29-853-8849
hsr@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Tsukuba Clinical Research & Development Organization
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-3914
Homepage URL
kensukeshimada.s@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
Tel
+81-29-853-3914
kensukeshimada.s@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
R05-233
Org. issuing International ID_1
University of Tsukuba Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 14 | 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
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2027 | 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 uses the dataset created by the "Large-scale observational study on the quality of perioperative care using perioperative dataset from the University of Tsukuba Hospital (R03-068)".
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062458
