UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of hydroxyethyl starch 130/0.4 on perioperative renal function in patients undergoing cardiac surgery
Title of the study (Brief title)	Effect of HES 130/0.4 on renal function in cardiac surgery
Region	Japan

Condition
Condition	cardiac diseases which require cardiac surgery
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation into the effect of hydroxyethyl starch 130/0.4 on renal function in cardac surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Acute kidney injury within 30days after cardiac surgery
Key secondary outcomes	serum Cystatin C, urine L-FABP, and beta 2 microglobulin in postoperative days

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration of bicarbonate riger solution and hydroxyethyl starch 130/0.4 during surgery
Interventions/Control_2	administration of bicarbonate riger solution
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 requiring cardiopulmonary bypass
Key exclusion criteria	eGFR<45ml/min/1.73m2 urgent surgery reoperation anaphylaxis for hydroxyethyl starch
Target sample size	60

Research contact person
Name of lead principal investigator	Kei Nagaya
Organization	Tohoku medical and pharmaceutical university hospital
Division name	division of anesthesia
Address	1-12-1 fukumuro, miyagino-ku, sendai, miyagi
TEL	022-259-1221
Email	k-nagaya@hosp.tohoku-mpu.ac.jp

Public contact
Name of contact person	Sadao Hatanaka
Organization	Tohoku medical and pharmaceutical university hospital
Division name	Tikenn Center
Address	1-12-1 fukumuro, miyagino-ku, sendai, miyagi
TEL	022-259-1221
Homepage URL
Email	tikenn@hosp.tohoku-mpu.ac.jp

Sponsor
Institute	Tohoku medical and pharmaceutical university hospital
Institute
Department

Funding Source
Organization	Tohoku medical and pharmaceutical university hospital
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 11 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 11 Day
Anticipated trial start date	2014 Year 04 Month 07 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

Management information
Registered date	2016 Year 11 Month 29 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028833