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Recruitment status Completed
Unique ID issued by UMIN UMIN000011650
Receipt No. R000013621
Scientific Title Low dose atrial natriuretic peptide provides effective renal protection from acute kidney injury after aortic arch surgery: a randomised controlled trial
Date of disclosure of the study information 2013/09/04
Last modified on 2013/09/04

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Basic information
Public title Low dose atrial natriuretic peptide provides effective renal protection from acute kidney injury after aortic arch surgery: a randomised controlled trial
Acronym Kawasaki ANP trial
Scientific Title Low dose atrial natriuretic peptide provides effective renal protection from acute kidney injury after aortic arch surgery: a randomised controlled trial
Scientific Title:Acronym Kawasaki ANP trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate whether an intravenous atrial natriuretic peptide infusion prevents acute kidney injury in patients undergoing aortic arch surgery requiring deep hypothermic circulatory arrest.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary end point was the incidence of AKI within 48 hours after surgery.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Patients are randomly assigned to receive a fixed dose of atrial natriuretic peptide (0.0125microgram kg-1 min-1) or placebo. The infusion is started after induction of anesthesia and continued for 24 hours postoperatively.
Interventions/Control_2 equivalent volume of 5% glucose (placebo)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a) elective aortic arch surgery;
b) preoperative serum creatinine under 1.3 mg/dL
Key exclusion criteria 1) an additional procedure was planned or undertaken
2) the arterial or venous cannulation sites were modified
3) the patient required an ANP infusion to treat perioperative acute heart failure
4) the patient age under 20 years
5) the patient had a history of adverse reaction to atrial natriuretic peptide
6) mean arterial blood pressure could not be maintained above 50 mmHg despite the administration of a positive inotrope or vasopressor after weaning from cardiopulmonary bypass.
Target sample size 43

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yosuke Mori
Organization Kawasaki Saiwai Hospital
Division name Department of Anesthesia
Zip code
Address 31-27 Omiya, Saiwai, Kawasaki, Kanagawa, Japan
TEL 044-544-4611
Email yosuke@mori.name

Public contact
1st name of contact person
1st name
Middle name
Last name Yosuke Mori
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
Email yosuke@mori.name

Sponsor
Institute Kawasaki Saiwai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kawasaki Saiwai Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 04 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
2011 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 05 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 09 Month 04 Day
Last modified on
2013 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013621


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