Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response (AMELIORATE)

Pere Gines

Status and phase: Unknown; Phase 4

Conditions: Hepatorenal Syndrome Type I; Cirrhosis

Treatments: Drug: Terlipressin and albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01530711

AMELIORATE

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

terlipressin

Experimental group

Treatment:

Drug: Terlipressin and albumin