UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021214
Receipt number R000024461
Scientific Title Clinical factors of hyperglycemia in children after surgery for congenital heart disease and thier prognosis
Date of disclosure of the study information 2016/02/26
Last modified on 2019/01/24 21:28:33

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Basic information

Public title

Clinical factors of hyperglycemia in children after surgery for congenital heart disease and thier prognosis

Acronym

Hyperglycemia after surgery for congenital heart disease

Scientific Title

Clinical factors of hyperglycemia in children after surgery for congenital heart disease and thier prognosis

Scientific Title:Acronym

Hyperglycemia after surgery for congenital heart disease

Region

Japan


Condition

Condition

Congenital heart diseases which underwent open heart surgery

Classification by specialty

Pediatrics Anesthesiology Cardiovascular surgery
Intensive care medicine Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Hyperglycemia after congenital heart disease in infants and children are reported to be related with worse outcomes. Opposit reports, on the other hand, also exist. Some reports show faictors contributing to hyperglycemia, but that is still uncertain.
This study is aimed to investigate clinical factors related to hyperglycemia and the effects of hyperglycemia on clinical outcomes.

Basic objectives2

Others

Basic objectives -Others

Hyperglycemia after congenital heart disease in infants and children are reported to be related with worse outcomes. Opposit reports, on the other hand, also exist. Some reports show faictors contributing to hyperglycemia, but that is still uncertain.
This study is aimed to investigate clinical factors related to hyperglycemia and the effects of hyperglycemia on clinical outcomes.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Background clinical status, length of postoperative mechanical ventilation and length of ICU stay are compared betweenn patients with hyperglycemia and euglycemia.

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

1 months-old <=

Age-upper limit

180 months-old >

Gender

Male and Female

Key inclusion criteria

Patients who underwent cardiac surgery for congenital heart diseases using cardiopulmonary bypass at the age of 1 month to 15 years and who were admitted to intensive care unit after the surgery.

Key exclusion criteria

Patients who died soon after the surgry and needed mechanical ventilation more than 2 weeks after the surgery were excluded.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Takaki

Organization

Yokohama City University

Division name

Intensive Care Unit

Zip code


Address

Fukuura3-9, Yokohama, Japan

TEL

045-787-2800

Email

anesthes@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Natsuhiro Yamamoto

Organization

Yokohama City University

Division name

Intensive Care Unit

Zip code


Address

Fukuura3-9, Yokohama, Japan

TEL

045-787-2800

Homepage URL


Email

anesthes@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Anaesthesiology and Intensive Care Unit, Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

2016 Year 02 Month 26 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2016 Year 02 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Hyperglycemia is defined as blood glucose over 250mg/dL and below it is defined as euglycemia. Preoperative factors such as age, height, body weight, past medical history and chromosomal abnormality are reviewed. In addition, operative factors (operative time, cardiopulmonary time, anesthetic factors,labo data and vital sighns) and postoperative factors (length of mechanical ventilation, length of ICU stay and vital sighns) are also corrected.


Management information

Registered date

2016 Year 02 Month 26 Day

Last modified on

2019 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name