TrAtaMiEnto deL sIndrOme hepatoRrenAl con TErlipresina en infusión ajustada a la respuesta hemodinámica.

Phase 1

Conditions: Hepatorenal syndrome (HRS) type 1
MedDRA version: 14.1Level: PTClassification code 10019846Term: Hepatorenal syndromeSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-002166-20-ES

Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Patients with type 1 HRS.
- Signed Informed consent.
- No exclusion criteria.
- Age> 18 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma having more than 3 nodules, single nodule larger than 5 cm, tumor portal vein thrombosis or extrahepatic tumor spread.
- Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension or septic CBC).
- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To observe the effect of terlipressin on renal function in patients with HRS Type 1 by adjusting the dose based on the hemodynamic response;Secondary Objective: - Determine the predictors of response to treatment.<br>- Evaluate the safety and adverse effects.;Primary end point(s): To observe the effect of terlipressin on renal function in patients with HRS Type 1 by adjusting the dose based on the hemodynamic response.;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Determine the predictors of response to treatment.<br>- Evaluate the safety and adverse effects.;Timepoint(s) of evaluation of this end point: N/A