UMIN-CTR Clinical Trial

Basic information
Public title	The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Acronym	The effect of postoperative delirium on a cardiopulmonary exercise testing
Scientific Title	The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Scientific Title:Acronym	The effect of postoperative delirium on a cardiopulmonary exercise testing
Region	Japan

Condition
Condition	Aged patients undergoing cardiac surgery
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of delirium on cardiopulmonary exercise testing at discharge
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AT-VO2 VE/VCO2 slope
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	70 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	cardiac surgical patients
Key exclusion criteria	patients who did not dischage
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yuta Middle name Last name Shimomoto
Organization	Sakurabashi-Watanabe Hospital
Division name	Rehabilitation
Zip code	530-0001
Address	2-4-32 Umeda Kita-ku, Osaka , Japan
TEL	06-6341-8651
Email	fa-7y.28_5a.15@outlook.jp

Public contact
Name of contact person	1st name Yukio Middle name Last name Hayashi
Organization	Sakurabashi-Watanabe Hospital
Division name	Anesthesiology
Zip code	530-0001
Address	2-4-32 Umeda Kita-ku Osaka, Japan
TEL	06-6341-8651
Homepage URL
Email	yhayashi@anes.med.osaka-u.ac.jp

Sponsor
Institute	Sakurabashi-Watanabe Hospital
Institute
Department

Funding Source
Organization	Sakurabashi-Watanabe Hospital
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	Sakurabashi-Watanabe Hospital IRB
Address	2-4-32 Umeda Kita-ku Osaka, Japan
Tel	06-6341-8651
Email	i_oka@watanabe-hsp.or.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	2022 Year 05 Month 09 Day

Related information
URL releasing protocol	http://www.watanabe-hsp.or.jp/hospitalinfo/optout
Publication of results	Unpublished

Result
URL related to results and publications	https://www.meeting-schedule.com/jsicm47/author.html
Number of participants that the trial has enrolled	70
Results	AT-VO2 and the slope of VCO2 and VE in the presence and absence of delirium and both values were comparable between the groups.
Results date posted	2022 Year 05 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Seventy patients aged 70 or older undergoing cardiac valve surgery, entered our ICU and were discharged from our hospital between June 2016 and July 2018.
Participant flow	All patients received active exercise from our rehabilitation team since the first postoperative day while on mechanical ventilation, and performed a CPX on a cycle ergometer before discharge.
Adverse events	No problem
Outcome measures	AT-VO2　VE/VCO2slope
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 01 Day
Date of IRB	2019 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 05 Month 09 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045410

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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