Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Phase 4

• Conditions: Hepatorenal Syndrome Type I; Cirrhosis
• Interventions: Drug: Terlipressin and albumin

• Registration Number: NCT01530711
• Lead Sponsor: Pere Gines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-18
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
terlipressin	Terlipressin and albumin	-

Primary Outcome Measures

Name	Time	Method
Changes in arterial pressure and creatinine	4 months

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Moisés Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Vall d´Hebron; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain