UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011558 |
|---|---|
| Receipt number | R000013522 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2013/08/22 |
| Last modified on | 2016/09/07 00:04:01 |
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Basic information
Public title
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
Acronym
Kawasaki biomarkers trial
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takaaki Kamada |
Organization
Kawasaki Saiwai Hospital
Division name
Department of anesthesia
Zip code
Address
31-27 Omiya, Saiwai, Kawasaki, Kanagawa, Japan
TEL
044-544-4611
tkamada0117@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Kamada |
Organization
Kawasaki Saiwai Hospital
Division name
Department of anesthesia
Zip code
Address
31-27 Omiya, Saiwai, Kawasaki, Kanagawa, Japan
TEL
044-544-4611
Homepage URL
tkamada0117@nifty.com
Sponsor or person
Institute
Kawasaki Saiwai Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 08 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013522
