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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022131
Receipt No. R000023429
Scientific Title Retrospective cohort study to examine the possibility of catecholamine administration prediction in cardiac surgery by the mitral annulus velocity
Date of disclosure of the study information 2016/04/30
Last modified on 2016/10/29

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Basic information
Public title Retrospective cohort study to examine the possibility of catecholamine administration prediction in cardiac surgery by the mitral annulus velocity
Acronym Retrospective cohort study to examine the possibility of catecholamine administration prediction in cardiac surgery by the mitral annulus velocity
Scientific Title Retrospective cohort study to examine the possibility of catecholamine administration prediction in cardiac surgery by the mitral annulus velocity
Scientific Title:Acronym Retrospective cohort study to examine the possibility of catecholamine administration prediction in cardiac surgery by the mitral annulus velocity
Region
Japan

Condition
Condition cardiac disease
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the significance of tissue doppler imaging for the prediction of postoperative infusion of catecholamine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes use of inotropic agents 18h after ICU admission
Key secondary outcomes use of inotropic agents 0h, 12h, 24h, and 48h after ICU admission, length of mechanical ventilation, length of ICU stay, length of postoperative hospital stay

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 undergoing cardiac surgery under CPB
Key exclusion criteria ・emergency procedures
・thoracic aortic surgery
・post mitral surgery
・patients with paced or non-sinus rhythm at the time of tissue Doppler measurements
・cases complications can not be denied due to surgery
・patients had adverse events that could cause a severe circulation change
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Kuroiwa
Organization Gunma Cardiovascular Center
Division name Division of Anesthesiology
Zip code
Address 3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL 027-269-7455
Email ykuroiwa54@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Kuroiwa
Organization Gunma Cardiovascular Center
Division name Division of Anesthesiology
Zip code
Address 3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL 027-269-7455
Homepage URL
Email ykuroiwa54@gmail.com

Sponsor
Institute Gunma Cardiovascular Center
Institute
Department

Funding Source
Organization Gunma prefectual cardiovascular center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of anesthesiology, Gunma university graduate school of medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 04 Month 30 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
2015 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data collection
A medical history was obtained including age, sex, height, body weight, complications. Preoperative LV ejection fraction (LVEF) was also collected and it was measured with transthoracic echocardiography (TTE). Surgical data was including type of surgery, CPB time, and aortic cross-clamping time. Postoperative data was including type of inotropic agents 0h, 12h, 18h, 24h and 48h after intensive care unit (ICU) admission, length of mechanical ventilation, length of ICU stay, length of postoperative hospital stay. TEE examination was performed after induction of general anesthesia and before sternotomy in hemodynamically stable condition.
Outcome variables
The primary outcome variable was use of inotropic agents 18h after ICU admission. Secondary outcome variables were use of inotropic agents 0h, 12h, 24h, and 48h after ICU admission, length of mechanical ventilation, length of ICU stay, length of postoperative hospital stay.
The primary outcome variable was use of inotropic agents 0h, 18h, 12h, 24h, and 48h after ICU admission. Secondary outcome variables were length of mechanical ventilation, length of ICU stay, length of postoperative hospital stay.

Management information
Registered date
2016 Year 04 Month 29 Day
Last modified on
2016 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023429

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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