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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014991
Receipt No. R000017262
Scientific Title The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Date of disclosure of the study information 2014/09/01
Last modified on 2019/06/09

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Basic information
Public title The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Acronym The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Scientific Title The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Scientific Title:Acronym The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Region
Japan

Condition
Condition cardiac surgery/Major vascular surgery
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Surgery in general Vascular surgery Anesthesiology
Cardiovascular surgery Blood transfusion Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the association of blood glucose management and presence of hemolysis with incidence of postoperative complications in cardiovascular surgery with cardiopulmonary bypass.
Basic objectives2 Others
Basic objectives -Others To observe the association of the peri-operative management with the incidence of postoperative complications including delirium and organ failures in cardiovascular surgery with cardiopulmonary bypass.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of acute kidney injury (RIFLE criteria)
Key secondary outcomes The duration of postoperative hospital stay
The duration of postoperative ICU stay
The duration required postoperative mechanical ventilatory support
The presence of organ failures (SOFA score)
The presence of postoperative respiratory complications associated with mechanical ventilation (VAC criteria)
The incidence of postoperative delirium (CAM-ICU)
The strength of oxidative stress

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 Patients over 20 years old undergoing cardiovascular using cardiopulmonary bypass at Kobe University Hospital.
Those who obtained informed consent related with this study.
Key exclusion criteria Patients with chronic renal dysfunction (serum creatinine is equal or more than 2mg/dL)
Patients who require hemodialysis.
patients with any conditions which cause hemolysis.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Moritoki
Middle name
Last name Egi
Organization Kobe University Hospital
Division name Anesthesiology
Zip code 6500017
Address 7-5-2 Kusunokicho Chuoku, Kobe, Hyogo
TEL 0783826172
Email moriori@tg8.so-net.ne.jp

Public contact
Name of contact person
1st name Kenta
Middle name
Last name Kubota
Organization Kobe University Hospital
Division name Anesthesiology
Zip code 6500017
Address 7-5-2 Kusunokicho Chuoku, Kobe, Hyogo
TEL 0783826172
Homepage URL
Email kentanyl@gmail.com

Sponsor
Institute Kobe University Hospital, Anesthesiology Department
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB comittee Kobe University hospital
Address 7-5-2 kusunokityo Kobe city hyogo
Tel 078-382-5111
Email moriori@tg8.so-net.ne.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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 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 Open public recruiting
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
2014 Year 08 Month 31 Day
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2021 Year 08 Month 01 Day

Other
Other related information ?

Management information
Registered date
2014 Year 08 Month 29 Day
Last modified on
2019 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017262

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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