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

August 17, 2016 updated by: Pere Gines
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08036
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Vall D´Hebron
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Hospital Moisès Broggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in arterial pressure and creatinine
Time Frame: 4 months
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pere Gines

Investigators

  • Principal Investigator: German Soriano Pastor, MD, gsoriano@santpau.cat
  • Principal Investigator: Juan Cordoba, MD, jcordoba@vhebron.net
  • Principal Investigator: Isabel Cirera Lorenzo, MD, ICirera@parcdesalutmar.cat
  • Principal Investigator: Marta Martín Llahí, MD, martinllahi@gmail.com
  • Principal Investigator: Jordi Sánchez Delgado, MD, jsanchezd@tauli.cat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMELIORATE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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