Terlipressin in the treatment of hepatorenal syndrome

• Grant number: 12/51234-9
• Support Opportunities: Research Grants - Research in Public Policies for the National Health Care System (PP-SUS)
• Duration: July 01, 2013 - January 31, 2016
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Convênio/Acordo: CNPq - PPSUS
• Principal Investigator: Rita de Cássia Martins Alves da Silva
• Grantee: Rita de Cássia Martins Alves da Silva
• Host Institution: Hospital de Base de São José do Rio Preto (HB). Fundação Faculdade Regional de Medicina (FUNFARME). São José do Rio Preto , SP, Brazil

Abstract

Hepatorenal syndrome (HRS) is a potentially reversible cause of acute renal failure (ARF) in patients with advanced cirrhosis and ascites, with high mortality. It is related to intense splanchnic arterial vasodilation with consequent reduction in effective arterial blood volume, and maintaining circulatory function will fall mainly on the renal circulation, with severe renal vasoconstriction and decreased glomerular filtration rate characterizing the HRS. In type-1 HRS kidney function deteriorates rapidly with creatinine > 2.5 mg/dL within 2 weeks. Type-2 HRS is characterized by slow or stable Progressive loss of renal function and creatinine are usually between 1.5 to 2.5 mg/dL. Untreated, the median survival for type-1 and type-2 HRS is 2 weeks and 4 to 6 months, respectively. Systemic vasoconstrictors associated with albumin neutralize the intense splanchnic arterial vasodilation, improve the effective arterial blood volume and are well indicated in type-1 HRS. Terlipressin is the first line treatment of type-1 HRS, according to the European guidelines. In the United States, due to unavailability of terlipressin, midodrine and octreotide association is preferred. In Brazil, midodrine is not an ANVISA approved drug. For Unified Health System (SUS) in Brazil can regulate the pharmacological treatment of HRS in its guidelines and thereby maintain the levei of excellence in service to the Brazilian people, is important more information is provided. This project proposes to evaluate the safety and efficacy of terlipressin in the treatment of type-1 HRS. The study will include patients aged 18 to 75 years, diagnosed with liver cirrhosis by histological or clinicai criteria, and with type-1 HRS. It is estimated to include 30 patients in the period of 18 months. Terlipressin will be administered associated with human albumin for up to 14 days depending on the evaluation of therapeutic response. The primary endpoint will be the complete response (creatinine < 1.6 mg/dL). .. (AU)