UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022131
Receipt number 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 13:03:28

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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 or person

Institute

Gunma Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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