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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000329 |
Receipt No. | 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 |
Basic information | ||
Public 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. | |
Acronym | A randomized controlled trial evaluating the renoprotective effect of carperitide in liver transplant recipients. | |
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. | |
Scientific Title:Acronym | A randomized controlled trial evaluating the renoprotective effect of carperitide in liver transplant recipients. | |
Region |
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Condition | ||
Condition | liver transplantation recipients | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | 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 |
Key secondary outcomes | 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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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. | |
Interventions/Control_2 | Dose up of conventional diuretics(flosemide; up to 2mg/kg/day, pottassium canrenoate; up to 8mg/kg/day ) alone. | |
Interventions/Control_3 | ||
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Interventions/Control_6 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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). | |||
Key exclusion criteria | 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. |
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Target sample size | 50 |
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Name of lead principal investigator |
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Organization | University of Tokyo | ||||||
Division name | Artificial Organ and Transplantation Division, Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655 | ||||||
TEL | +81-3-3815-5411 | ||||||
yasusuga-tky@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of Tokyo | ||||||
Division name | Artificial Organ and Transplantation Division, Hepato-Biliary-Pancreatic Surgery Division, Departme | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655 | ||||||
TEL | 03-3815-5411 | ||||||
Homepage URL | |||||||
yasusuga-tky@umin.ac.jp |
Sponsor | |
Institute | The Artificial Organ and Transplantation Division, Department of Surgery |
Institute | |
Department |
Funding Source | |
Organization | The Artificial Organ and Transplantation Division, Department of Surgery |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
Institutions | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000374 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |