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

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ClinicalTrials.gov Identifier: NCT01530711
Recruitment Status : Active, not recruiting
First Posted : February 10, 2012
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
Pere Gines, Hospital Clinic of Barcelona

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 : April 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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.

Primary Outcome Measures :
  1. Changes in arterial pressure and creatinine [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Changes in plasmatic renin activity and aldosterone and noradrenaline concentration. [ Time Frame: 4 months ]
  2. Treatment-related adverse events [ Time Frame: 4 months ]
  3. Hepatorenal Syndrome reversion due to hemodynamic changes. [ Time Frame: 4 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530711

Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital Moisés Broggi
Sant Joan Despí, Barcelona, Spain, 08970
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08036
Hospital Vall d´Hebron
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Pere Gines
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

Responsible Party: Pere Gines, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01530711     History of Changes
Other Study ID Numbers: AMELIORATE
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Hepatorenal Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Antihypertensive Agents
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs