Unique ID issued by UMIN | UMIN000001462 |
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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 |
Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis.
NU-HIT trial for CRF
Effective of hANP for cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis.
NU-HIT trial for CRF
Japan |
myocardial infarction, angina, valvular disease, thoracic aortic aneurysm
Cardiovascular surgery |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase II
presence of dialysis
eGFR
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Medicine |
Perioperative administration of hANP
Perioperative non-administration of hANP
20 | years-old | <= |
80 | years-old | > |
Male and Female
patient undergoing cardiac surgery
eGFR>60
Patients from whom informed consent was obtained
cardiogenic shock
dialysis-dependent patient
100
1st name | |
Middle name | |
Last name | Akira Sezai |
Nihon University School of Medicine
Department of Cardiovascular Surgery
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
03-3972-8111
1st name | |
Middle name | |
Last name | Akira Sezai |
Nihon University School of Medicine
Department of Cardiovascular Surgery
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
03-3972-8111
asezai.med@gmail.com
Nihon University School of Medicine
self funding
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.
NO
2008 | Year | 10 | Month | 29 | Day |
Unpublished
Completed
1997 | Year | 03 | Month | 10 | Day |
1997 | Year | 03 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2009 | Year | 06 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2008 | Year | 10 | Month | 29 | Day |
2011 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001778
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