Terlipressin and albumin vs albumin in patients with cirrhosis and hepatorenal syndrome: a randomized study.
OBJECTIVE
Hepatorenal syndrome is common in patients with advanced cirrhosis and constitutes a major problem in liver transplantation. There is no effective medical treatment for hepatorenal syndrome.


METHODS
Forty-six patients with cirrhosis and hepatorenal syndrome, hospitalized in a tertiary care center, were randomly assigned to receive either terlipressin (1-2 mg/4 hour, intravenously), a vasopressin analogue, and albumin (1 g/kg followed by 20-40 g/day) (n = 23) or albumin alone (n = 23) for a maximum of 15 days. Primary outcomes were improvement of renal function and survival at 3 months.


RESULTS
Improvement of renal function occurred in 10 patients (43.5%) treated with terlipressin and albumin compared with 2 patients (8.7%) treated with albumin alone (P = .017). Independent predictive factors of improvement of renal function were baseline urine volume, serum creatinine and leukocyte count, and treatment with terlipressin and albumin. Survival at 3 months was not significantly different between the 2 groups (terlipressin and albumin: 27% vs albumin 19%, P = .7). Independent predictive factors of 3-month survival were baseline model for end-stage liver disease score and improvement of renal function. Cardiovascular complications occurred in 4 patients treated with albumin alone and in 10 patients treated with terlipressin and albumin, yet permanent terlipressin withdrawal was required in only 3 cases.


CONCLUSIONS
As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Further studies with large sample sizes should be performed to test whether the improvement of renal function translates into a survival benefit.
Martín-Llahí
Marta
M
Liver Unit, Hospital Clínic, University of Barcelona School of Medicine, Institut d'Investigacions Biomèdiques August Pi-Sunyer (IDIBAPS), Centro de Investigacíon Biomedica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain.
Pépin
Marie-Noëlle
MN
Guevara
Mónica
M
Díaz
Fernando
F
Torre
Aldo
A
Monescillo
Alberto
A
Soriano
Germán
G
Terra
Carlos
C
Fábrega
Emilio
E
Arroyo
Vicente
V
Rodés
Juan
J
Ginès
Pere
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006530:Hepatorenal Syndrome / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D006801:Humans; D007275:Injections, Intravenous; D007677:Kidney Function Tests; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008236:Lypressin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012772:Shock, Septic; D015996:Survival Rate / Q000639:trends; D000077585:Terlipressin; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014662:Vasoconstrictor Agents / Q000008:administration & dosage*
D000418:Albumins; D014662:Vasoconstrictor Agents; D008236:Lypressin; D000077585:Terlipressin