UMIN-CTR Clinical Trial

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
Last 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
Email	tkuwata@dokkyomed.ac.jp

Public contact
1st 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
Email	tkuwata@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032876