UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical factors of hyperglycemia in children after surgery for congenital heart disease and thier prognosis
Title of the study (Brief title)	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	Shunsuke Takaki
Organization	Yokohama City University
Division name	Intensive Care Unit
Address	Fukuura3-9, Yokohama, Japan
TEL	045-787-2800
Email	anesthes@yokohama-cu.ac.jp

Public contact
Name of contact person	Natsuhiro Yamamoto
Organization	Yokohama City University
Division name	Intensive Care Unit
Address	Fukuura3-9, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	anesthes@yokohama-cu.ac.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024461