Cirrhosis, Hepatorenal Syndrome Type I
Conditions
Brief summary
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.
Interventions
Terlipressin dose: 2mg/24h, it will be modified depending on: Arterial pressure increase \< 10 mmHg and the creatinine values decrease \<25%, it will be increased every 8 hours until reaching an increase of at least 10mmHg arterial pressure or a creatinine decrease of the 25%. Albumin: Initial dose (first day) of 1g/Kg (up to a maximum of 100g) and the following days from 20 to 40 g/day.
Sponsors
Pere Gines
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with hepatorenal syndrome type 1. * Signed informed consent. * No
Exclusion criteria
. * At least 18 years old * Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in arterial pressure and creatinine | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in plasmatic renin activity and aldosterone and noradrenaline concentration. | 4 months |
| Treatment-related adverse events | 4 months |
| Hepatorenal Syndrome reversion due to hemodynamic changes. | 4 months |
Countries
Spain
Outcome results
None listed