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

Primary Purpose

Cirrhosis, Hepatorenal Syndrome Type I

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Terlipressin and albumin

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Corporació Sanitària Parc Taulí
Hospital Moisés Broggi
Hospital Clinic i Provincial de Barcelona
Hospital del Mar
Hospital Vall d´Hebron
Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

terlipressin

Arm Description

Outcomes

Primary Outcome Measures

Changes in arterial pressure and creatinine

Secondary Outcome Measures

Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.

Treatment-related adverse events

Hepatorenal Syndrome reversion due to hemodynamic changes.

Full Information

NCT ID

NCT01530711

First Posted

February 9, 2012

Last Updated

August 17, 2016

Sponsor

Pere Gines

1. Study Identification

Unique Protocol Identification Number

NCT01530711

Brief Title

Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Acronym

AMELIORATE

Official Title

Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pere Gines

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Hepatorenal Syndrome Type I

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

terlipressin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Terlipressin and albumin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in arterial pressure and creatinine

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.

Time Frame

4 months

Title

Treatment-related adverse events

Time Frame

4 months

Title

Hepatorenal Syndrome reversion due to hemodynamic changes.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: