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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name