UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001462
Receipt number R000001778
Scientific Title Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis.
Date of disclosure of the study information 2008/10/29
Last modified on 2011/03/14 09:26:15

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Basic information

Public title

Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis.

Acronym

NU-HIT trial for CRF

Scientific Title

Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis.

Scientific Title:Acronym

NU-HIT trial for CRF

Region

Japan


Condition

Condition

myocardial infarction, angina, valvular disease, thoracic aortic aneurysm

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The risk of cardiac surgery in a patient with renal dysfunction is high. We conducted the effect of hANP infusion for a patient with renal dysfunction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

presence of dialysis
eGFR

Key secondary outcomes

mortality ,survival rate ,complication, BNP, ANP, renin activity, angiotensin II, aldosterone, blood urea reno-event free rate, nitrogen (BUN), Cr, sodium (Na), osmotic pressure (Osm),Urinary Na (U-Na), urinary Cr (U-Cr), and osmotic pressure (U-osm)
creatinine clearance Ccr, fractional sodium excretion, free water clearance and renal failure index


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Perioperative administration of hANP

Interventions/Control_2

Perioperative non-administration of hANP

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

patient undergoing cardiac surgery
eGFR>60
Patients from whom informed consent was obtained

Key exclusion criteria

cardiogenic shock
dialysis-dependent patient

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan

TEL

03-3972-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan

TEL

03-3972-8111

Homepage URL


Email

asezai.med@gmail.com


Sponsor or person

Institute

Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

a grant for the 60th anniversary of the Alumni Association of Nihon University School of Medicine and for the 50th anniversary of the foundation of Nihon University School of Medicine.


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

2008 Year 10 Month 29 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

1997 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

1997 Year 03 Month 01 Day

Last follow-up date

2009 Year 05 Month 01 Day

Date of closure to data entry

2009 Year 05 Month 01 Day

Date trial data considered complete

2009 Year 06 Month 01 Day

Date analysis concluded

2009 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 29 Day

Last modified on

2011 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name