Unique ID issued by UMIN | C000000329 |
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Receipt number | R000000374 |
Scientific Title | A randomized controlled trial comparing renoprotective effect of conventional diuretics (furocemide and potassium canrenoate) with carperitide and conventional diuretics alone in liver transplant recipients. |
Date of disclosure of the study information | 2006/02/10 |
Last modified on | 2015/08/08 09:23:52 |
A randomized controlled trial comparing renoprotective effect of conventional diuretics (furocemide and potassium canrenoate) with carperitide and conventional diuretics alone in liver transplant recipients.
A randomized controlled trial evaluating the renoprotective effect of carperitide in liver transplant recipients.
A randomized controlled trial comparing renoprotective effect of conventional diuretics (furocemide and potassium canrenoate) with carperitide and conventional diuretics alone in liver transplant recipients.
A randomized controlled trial evaluating the renoprotective effect of carperitide in liver transplant recipients.
Japan |
liver transplantation recipients
Hepato-biliary-pancreatic surgery |
Others
NO
To compare the renoprotective effect of conventional diuretics (furosemide and pottassium canrenoate) combined with carperitide (hANP), and conventional diuretics alone in patients with renal insufficiency after liver transplantation.
Efficacy
Exploratory
Pragmatic
Phase II
The number (rate) of cases requiring induction of hemo-dialysis due to insufficient diuresis fulfilling the following criteria.
1)Serum creatinine of >6.0mg/dl
2)Oliguria(1ml/kg/hr)lasting over 6hours
3)Serum potassium of > 6.0mEq/l
1)Body weight
2)Blood pressure, pulse rate, urine volume
3)Serum creatinine, urea nitrogen
4)Serum atrial natriuretic peptide, aldosterone, brain natriuretic peptide, cyclic GMP
5)Serum renin activity
6)Urine creatinine
7)Urine NAG
8)Urine L-FABP
9)creatinine clearance
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
2
Treatment
Medicine |
Intravenous administration of carperitide by the central dose of 0.1ug/kg/min, which is modulated between 0.025 and 0.22ug/kg/min according to the reactive urination.
Dose up of conventional diuretics(flosemide; up to 2mg/kg/day, pottassium canrenoate; up to 8mg/kg/day ) alone.
18 | years-old | <= |
65 | years-old | >= |
Male and Female
Patient selection: Patients who present with the following findings despite the use of conventional diuretics (furocemide up to 0.4mg/kg/day and potassium canrenoate up to 4mg/kg/day) among those who fulfill the above conditions and agreed to participate; A.) Elevated serum creatinine more than oe equal to 1mg/dl compared to that of preoperative value. B.) Oliguria less than or equal to 1ml/kg/h within 3 days postoperatively (evaluated q6 hours).
Exclusion criteria
1) Patients on chronic hemo-dialysis.
2) Patients who required hemo-dialysis prior to transplantation. (Includes the use of continuous hemo-diafiltration for treating hepatic coma in fulminant hepatic failure)
3) Patients with underlying complications such as diabetes, hypertension, heart disease, hepatopulmonary syndrome, pulmonary hypertension etc.
4) Patients with renal disease other than hepatorenal syndrome.
5) Patients with contraindicated conditions for the use of studied agent such as pheochromocytoma, epilepsy, and right ventricle infarction.
6) Those that are considered ineligible by the participating physician.
50
1st name | |
Middle name | |
Last name | Yasuhiko Sugawara |
University of Tokyo
Artificial Organ and Transplantation Division, Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
+81-3-3815-5411
yasusuga-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Yasuhiko Sugawara |
University of Tokyo
Artificial Organ and Transplantation Division, Hepato-Biliary-Pancreatic Surgery Division, Departme
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
03-3815-5411
yasusuga-tky@umin.ac.jp
The Artificial Organ and Transplantation Division, Department of Surgery
The Artificial Organ and Transplantation Division, Department of Surgery
Self funding
NO
2006 | Year | 02 | Month | 10 | Day |
Unpublished
Completed
2005 | Year | 01 | Month | 27 | Day |
2005 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2006 | Year | 02 | Month | 08 | Day |
2015 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000374
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