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

• Sponsor: Pere Gines (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01530711
• Collaborator: (none)
• Enrollment: 40
• Locations: 6
• Arm: 1
• Duration (Months): 56
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis; Hepatorenal Syndrome Type I	Drug: Terlipressin and albumin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
• Study Start Date: Apr 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: terlipressin

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.

Outcome Measures

Primary Outcome Measures

1. Changes in arterial pressure and creatinine [4 months]

Secondary Outcome Measures

1. Changes in plasmatic renin activity and aldosterone and noradrenaline concentration. [4 months]

2. Treatment-related adverse events [4 months]

3. Hepatorenal Syndrome reversion due to hemodynamic changes. [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corporació Sanitària Parc Taulí	Sabadell	Barcelona	Spain	08208
2	Hospital Moisés Broggi	Sant Joan Despí	Barcelona	Spain	08970
3	Hospital Clinic i Provincial de Barcelona	Barcelona		Spain	08036
4	Hospital del Mar	Barcelona		Spain	08036
5	Hospital Vall d´Hebron	Barcelona		Spain	08036
6	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041

Sponsors and Collaborators

• Pere Gines

Investigators

• Principal Investigator: German Soriano Pastor, MD, [e-mail]
• Principal Investigator: Juan Cordoba, MD, [e-mail]
• Principal Investigator: Isabel Cirera Lorenzo, MD, [e-mail]
• Principal Investigator: Marta Martín Llahí, MD, [e-mail]
• Principal Investigator: Jordi Sánchez Delgado, MD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pere Gines, MD, PhD, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT01530711
• Other Study ID Numbers: AMELIORATE
• First Posted: Feb 10, 2012
• Last Update Posted: Aug 18, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Hepatorenal Syndrome; Syndrome; Terlipressin

Study Results

No Results Posted as of Aug 18, 2016