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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-UMIN000001462
Date of registration: 29/10/2008
Prospective Registration: No
Primary sponsor: Nihon University School of Medicine
Public title: Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis.
Scientific title: Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis. - NU-HIT trial for CRF
Date of first enrolment: 1997/03/01
Target sample size: 100
Recruitment status: Complete: follow-up complete
URL:  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001778
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Phase II
Countries of recruitment
Japan
Contacts
Name:     Akira Sezai
Address:  30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan Japan
Telephone: 03-3972-8111
Email:
Affiliation:  Nihon University School of Medicine Department of Cardiovascular Surgery
Name:     Akira Sezai
Address:  30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan Japan
Telephone: 03-3972-8111
Email: asezai.med@gmail.com
Affiliation:  Nihon University School of Medicine Department of Cardiovascular Surgery
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: cardiogenic shock dialysis-dependent patient

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
myocardial infarction, angina, valvular disease, thoracic aortic aneurysm
Intervention(s)
Perioperative administration of hANP
Perioperative non-administration of hANP
Primary Outcome(s)
presence of dialysis eGFR
Secondary Outcome(s)
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
Secondary ID(s)
Source(s) of Monetary Support
self funding
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.
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available: Yes
Date Posted:
Date Completed: 01/05/2009
URL:
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