UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002499
Receipt No. R000003063
Scientific Title Effective of hANP for CABG in patients with moderate to severe preoperative renal dysfunction without dialysis.
Date of disclosure of the study information 2009/09/15
Last modified on 2018/03/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effective of hANP for CABG in patients with moderate to severe preoperative renal dysfunction without dialysis.
Acronym NU-HIT trial for CRF
Scientific Title Effective of hANP for CABG 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
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 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes presence of dialysis
Cr, eGFR
Key secondary outcomes reno-event free rate, mortality ,survival rate ,complication, BNP, ANP, renin activity, angiotensin II, aldosterone, blood urea 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
90 years-old >
Gender Male and Female
Key inclusion criteria patient undergoing isolated CABG
eGFR>60
Patients from whom informed consent was obtained
Key exclusion criteria cardiogenic shock
dialysis-dependent patient
Target sample size 500

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, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email asezai.med@gmail.com

Sponsor
Institute Nihon University School of Medicine
Institute
Department

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
2009 Year 09 Month 15 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
1997 Year 06 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 15 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.