A randomized controlled trial comparing renoprotective effect of conventional diuretics (furocemide and potassium canrenoate) with carperitide and conventional diuretics alone in liver transplant recipients.

UMIN ID: C000000329

Registered date:10/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: liver transplantation recipients
• Date of first enrollment: 2005/12/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: 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
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: The Artificial Organ and Transplantation Division, Department of Surgery
• Source(s) of Monetary Support: The Artificial Organ and Transplantation Division, Department of Surgery