UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004537
Receipt number R000005421
Scientific Title A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for high risk patients undergoing cardiac surgery
Date of disclosure of the study information 2010/11/10
Last modified on 2018/03/26 11:21:24

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Basic information

Public title

A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for high risk patients undergoing cardiac surgery

Acronym

NU-HIT trial for High risk patients

Scientific Title

A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for high risk patients undergoing cardiac surgery

Scientific Title:Acronym

NU-HIT trial for High risk patients

Region

Japan


Condition

Condition

myocardial infarction, angina

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reserch the effects of continuous low-dose administration of hANP for high risk patients during and after caridac surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

major adverse cardiovascular and cerebrovascular events (MACCE)

Key secondary outcomes

1) postoperative death (early, late)
2) MACCE + hemodialysis (HD)
3) serum creatinine (sCr) and brain natriuretic peptide (BNP) levels at 1 week and 1 year postoperatively.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Perioperative administration of hANP (0.02ganma)

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

EuroScore>6 point
On pump CABG
Patients from whom informed consent was obtained

Key exclusion criteria

OPCAB
Combined surgery

Target sample size

350


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

asezai.med@gmail.com


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, Itabasi-ku, Tokyo

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)



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

2010 Year 11 Month 10 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 01 Day

Date of IRB


Anticipated trial start date

1997 Year 03 Month 01 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

2010 Year 11 Month 10 Day

Last modified on

2018 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005421


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name