UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pediatric predictive risk of cardio pulmonary bypass-associated acute kidney injury:retrospective study
Title of the study (Brief title)	Pediatric predictive risk of cardio pulmonary bypass-associated acute kidney injury:retrospective study
Region	Japan

Condition
Condition	pediatric cardiac surgery with cardio pulmonary bypass
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the risk factors of acute kidney injury after cardio pulmonary bypass in children.
Basic objectives2	Others
Basic objectives -Others	To investigate relation with hemoglobin concentration in cardio pulmonary bypass and risk of acute kidney injury
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin concentrarion in cardio pulmonary bypass
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	0 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	The patient who had a cardiac surgery with cardio pulmonary bypass between January 2014 and December 2015.
Key exclusion criteria	The patient who had renal failure before an operation. The patient who had a re-operation within one-week.
Target sample size	134

Research contact person
Name of lead principal investigator	Yuko nawa
Organization	Hokkaido Medical Center for Child Health and Rehabilitation
Division name	department of anesthesiology
Address	240-6,Kanayama 1-jo,1-chome,Teine-ku Sapporo-shi,Hokkaido,Japan
TEL	011-691-5696
Email	nawa@sapmed.ac.jp

Public contact
Name of contact person	Sho Ohno
Organization	Hokkaido Medical Center for Child Health and Rehabilitation
Division name	department of anesthesiology
Address	240-6,Kanayama 1-jo,1-chome,Teine-ku Sapporo-shi,Hokkaido,Japan
TEL	011-691-5696
Homepage URL
Email	sho.ohno21@gmail.com

Sponsor
Institute	Hokkaido Medical Center for Child Health and Rehabilitation
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	2017 Year 03 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 20 Day
Anticipated trial start date	2016 Year 11 Month 20 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	Unpublished
URL releasing results
Results
Other related information	retrospective observational study

Management information
Registered date	2017 Year 03 Month 16 Day
Last modified on	2017 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030523