UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031183
Receipt number R000035599
Scientific Title Utility of noninvasive regional saturation monitoring using with INVOS500 to predict prognosis in pediatric patients with congenital heart disease
Date of disclosure of the study information 2018/02/07
Last modified on 2018/02/07 11:36:03

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Basic information

Public title

Utility of noninvasive regional saturation monitoring using with INVOS500 to predict prognosis in pediatric patients with congenital heart disease

Acronym

Noninvasive regional saturation monitoring and congenital heart surgery

Scientific Title

Utility of noninvasive regional saturation monitoring using with INVOS500 to predict prognosis in pediatric patients with congenital heart disease

Scientific Title:Acronym

Noninvasive regional saturation monitoring and congenital heart surgery

Region

Japan


Condition

Condition

congenital heart disease

Classification by specialty

Anesthesiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the utility of noninvasive regional saturation monitoring in patients with congenital heart disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Poor outcomes including 30-day mortality, duration of ICU stay, duration of respiratory ventilation, administration of renal replacement therapy and ECMO

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

3 years-old >=

Gender

Male and Female

Key inclusion criteria

pediatric patients with congenital heart disease and body weight under 10 kg

Key exclusion criteria

body weight over 10 kg

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Saito

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

zaifu-cho 53, Hirosaki, Aomori, Japan

TEL

0172-39-5113

Email

masuika@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Saito

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Zaifu-cho 53, Hirosaki, Aomori, Japan

TEL

0172-39-5113

Homepage URL


Email

masuika@hirosaki-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Hirosaki University Graduate School of Medicine

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


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

2018 Year 02 Month 07 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

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

we measure cerebral and renal regional saturation preoperatively. we compared with regional saturation and other data including preoperative BNP, cardiac function, RACHS score and others.


Management information

Registered date

2018 Year 02 Month 07 Day

Last modified on

2018 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name