This trial is active, not recruiting.

Conditions cirrhosis, hepatorenal syndrome type i
Treatment terlipressin and albumin
Phase phase 4
Sponsor Pere Gines
Start date April 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT01530711, AMELIORATE


Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
terlipressin and albumin
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.

Primary Outcomes

Changes in arterial pressure and creatinine
time frame: 4 months

Secondary Outcomes

Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.
time frame: 4 months
Treatment-related adverse events
time frame: 4 months
Hepatorenal Syndrome reversion due to hemodynamic changes.
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

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. Exclusion Criteria: - Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread. - Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count). - Cardiac or respiratory failure clinically significant. - Clinically significant peripheral artery disease. - A history of ischemic heart disease. - Hypersensitivity to terlipressin and / or albumin or any of the excipients. - Pregnancy. - Septic shock. - Chronic renal failure. - Women in lactation

Additional Information

Official title Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
Principal investigator German Soriano Pastor, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.