UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of urinary biomarker for acute renal failure . And low dose atrial natriuretic peptide provides effective renal protection from acute kidney injury after thoracic aortic surgery: a randomised controlled trial
Title of the study (Brief title)	Kawasaki biomarkers trial
Region	Japan

Condition
Condition	thoracic aortic aneurysm acute kidney injury
Classification by specialty	Cardiology Nephrology Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Acute kidney injury (AKI) after surgery is associated with an increased risk of adverse events and death. Atrial natriuretic peptide (ANP) dilates the pre-glomerular renal artery and inhibits the renin-angiotensin axis. A low dose ANP infusion increases glomerular filtration rate after cardiovascular surgery,but it is not known whether it reduces the incidence of AKI or the mortality rate.To evaluate whether an intravenous ANP infusion prevents AKI in patients undergoing thoracic aortic surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the primary outcomes is the incidence of AKI within 48 hours after surgery.(serum creatinine,L-FABP,NGAL)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	administration of ANP(0.0125microgram kg-1 min-1) the infusion is started after induction of anesthesia and continued for 24 hours after surgery
Interventions/Control_2	administration of 5% glucose
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	1)thoracic aortic surgery 2)left heart bypass and cardiopulmonary bypass 3)preoperative serum creatinine1.5mg/dL or less 4)left femoral artery or escending aorta and left pulmonary vein
Key exclusion criteria	1)case of deep hypothermic circulatory arrest 2)the arterial or venous cannulation sites were modified
Target sample size	70

Research contact person
Name of lead principal investigator	Takaaki Kamada
Organization	Kawasaki Saiwai Hospital
Division name	Department of anesthesia
Address	31-27 Omiya, Saiwai, Kawasaki, Kanagawa, Japan
TEL	044-544-4611
Email	tkamada0117@nifty.com

Public contact
Name of contact person	Takaaki Kamada
Organization	Kawasaki Saiwai Hospital
Division name	Department of anesthesia
Address	31-27 Omiya, Saiwai, Kawasaki, Kanagawa, Japan
TEL	044-544-4611
Homepage URL
Email	tkamada0117@nifty.com

Sponsor
Institute	Kawasaki Saiwai Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, School of Medicine, Toho University
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	2013 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 22 Day
Anticipated trial start date	2013 Year 08 Month 22 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	2013 Year 08 Month 22 Day
Last modified on	2016 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013522