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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001440
Receipt No. R000001749
Scientific Title Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery
Date of disclosure of the study information 2008/10/20
Last modified on 2018/03/26

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Basic information
Public title Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery
Acronym Influence of human atrial natriuretic peptide on renal function during cardiac surgery
Scientific Title Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery
Scientific Title:Acronym Influence of human atrial natriuretic peptide on renal function during cardiac surgery
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 Acute renal failure occurs after cardiac surgery in 2.4-16% of patients who have normal renal function preoperatively, and the prognosis of such patients is relatively poor with a mortality rate of 1.3-30%. The mortality rate rises to 33-63.7% in patients requiring hemodialysis.
Human atrial natriuretic peptide (hANP) is a hormone that is secreted in response to stretching of the atrial wall. It has a vasodilatory effect, a potent natriuretic effect, suppresses the renin-angiotensin-aldosterone system (RASS), and causes coronary artery dilation, and has thus been used clinically as a new drug for the treatment of cardiac failure.
we conducted the effect of hANP infusion during CPB on postoperative renal function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes mortality
complication
Incidence of postoperative acute renal failure
maximum value and percent increase of Cr.
Key secondary outcomes pre-op, 0,1,3,7 days after surgery: 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) .
pre-op, 0,1,3,7 days after surgery: 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 Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

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 cardiac surgery
Patients from whom informed consent was obtained
Key exclusion criteria renal impairment(Cr>1.3mg/dl)
cardiogenic shock
Target sample size 700

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
2008 Year 10 Month 20 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
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 10 Month 20 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=R000001749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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