UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029985 |
|---|---|
| Receipt number | R000032876 |
| Scientific Title | Impact of diffusing capacity of the lung for carbon monoxide as predictor in early complication after cardiac surgery. |
| Date of disclosure of the study information | 2017/11/16 |
| Last modified on | 2019/05/18 21:29:58 |
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Basic information
Public title
Impact of diffusing capacity of the lung for carbon monoxide as predictor in early complication after cardiac surgery.
Acronym
DLco as predictor in early complication
Scientific Title
Impact of diffusing capacity of the lung for carbon monoxide as predictor in early complication after cardiac surgery.
Scientific Title:Acronym
DLco as predictor in early complication
Region
| Japan |
Condition
Condition
cardiac disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to determine whether DLco% values were predictors of postoperative complication after cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complicati after 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cardiac surgery
Key exclusion criteria
aortic surgery
emargency surgery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | TOSHIYUKI |
| Middle name | |
| Last name | KUWATA |
Organization
Dokkyo Medical University
Division name
Department of Cardiac and Vascular Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, 321-0923, Japan
TEL
0282-87-2301
tkuwata@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | TOSHIYUKI |
| Middle name | |
| Last name | KUWATA |
Organization
Dokkyo Medical University
Division name
Department of Cardiac and Vascular Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, 321-0923, Japan
TEL
0282-87-2301
Homepage URL
tkuwata@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University, Department of Cardiac and Vascular Surgery
Address
880 Kitakobayashi, Mibu, Tochigi, 321-0923, Japan
Tel
0282-87-2301
tkuwata@dokkyomed.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
| 2017 | Year | 11 | Month | 16 | 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
| 2017 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From June 2008 to December 2015, we performed cardiac surgeries in 2040 patients in Dokkyo Medical University Hospital. 408 patients in whom preoperative DLco were routinely collected within 1 week before scheduled cardiac surgery were included in this study. Patient physician made the decision to perform pulmonary function test including DLco based on clinical indications. Medical records were reviewed, including patients demographics, preoperative clinical date, results of pulmonary function test , hemodynamic data by cardiac catheterization, operative and postoperative data.
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032876
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
