Cirrhosis, Type 1 Hepatorenal Syndrome
Conditions
Keywords
cirrhosis, type 1 hepatorenal syndrome, terlipressin, albumin, effective circulating volume, Patients, with
Brief summary
It is well known that terlipressin and albumin improve renal function in patients with cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration of terlipressin have never been compared. Nevertheless, it has been hypothesized that continuous intravenous infusion assures a more steady profile of effect on portal pressure in patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type 1 HRS in patients with cirrhosis.
Interventions
DRUGterlipressin given by intravenous boluses and albumin
Patients who will be randomly assigned to arm 1 will received terlipressin given by intravenous boluses at the initial dose of terlipressin was 0.5 mg/4 hr. In case of non response, the dose of terlipressin was progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given intravenously at the dose of 1 g/kg of body weight on the first day followed by 20-40 g/day.
DRUGterlipressin given by continuous intravenous infusion and albumin
Patients who will be randomly assigned to arm 1 will received terlipressin given as intravenous boluses at the initial dose of 0.5 mg/4 hr. In case of non response, the dose of terlipressin will be progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given at the dose of 1 g/kg of body weight at the first day followed by 20-40 g/day.
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with cirrhosis and type 1 HRS
Exclusion criteria
* HCC beyond the Milan Criteria,septic shock (systolic arterial pressure \< 90 mmHg, * Significant heart or respiratory failure, * Peripheral arteriophaty clinically significant, * Previous heart stroke or significant alteration of the ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl). | The treatment will be continued for a maximum of 15 days |
Countries
Italy
Contacts
Primary ContactAlessandra Galioto, MD
Outcome results
None listed