Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Cirrhosis Clinical Trial

— AMELIORATE  

Official title:

Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01530711
• Other study ID #: AMELIORATE
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 9, 2012
• Last updated: August 17, 2016
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Hepatorenal Syndrome
• Hepatorenal Syndrome Type I
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d´Hebron	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital Moisés Broggi	Sant Joan Despí	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Pere Gines

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in arterial pressure and creatinine		4 months	No
Secondary	Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.		4 months	No
Secondary	Treatment-related adverse events		4 months	Yes
Secondary	Hepatorenal Syndrome reversion due to hemodynamic changes.		4 months	No