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

This study is currently recruiting participants.
Verified February 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Pere Gines, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01530711
First received: February 9, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Cirrhosis
Hepatorenal Syndrome Type I
 Drug: Terlipressin and albumin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Changes in arterial pressure and creatinine [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in plasmatic renin activity and aldosterone and noradrenaline concentration. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Treatment-related adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Hepatorenal Syndrome reversion due to hemodynamic changes. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530711

Contacts
Contact: Pere Ginès Gibert, MD +34 932275400 pgines@clinic.ub.es

Locations
Spain
Corporació Sanitària Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Jordi Sánchez Delgado, MD         jsanchezd@tauli.cat    
Principal Investigator: Jordi Sánchez Delgado, MD            
Hospital Moisés Broggi Not yet recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Contact: Marta Martín Llahí, MD         martinllahi@gmail.com    
Principal Investigator: Marta Martín Llahí, MD            
Hospital Vall d´Hebron Not yet recruiting
Barcelona, Spain, 08036
Contact: Juan Cordoba, MD         jcordoba@vhebron.net    
Principal Investigator: Juan Cordoba, MD            
Hospital del Mar Not yet recruiting
Barcelona, Spain, 08036
Contact: Isabel Cirera Lorenzo, MD         ICirera@parcdesalutmar.cat    
Principal Investigator: Isabel Cirera Lorenzo, MD            
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08041
Contact: German Soriano Pastor, MD         gsoriano@santpau.cat    
Principal Investigator: German Soriano Pastor, MD            
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Pere Gines, MD     93 227 54 00     PGINES@clinic.ub.es    
Principal Investigator: Pere Gines, MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Pere Gines, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01530711     History of Changes
Other Study ID Numbers: AMELIORATE
Study First Received: February 9, 2012
Last Updated: February 27, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Pathologic Processes
Terlipressin
Lypressin
Vasoconstrictor Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013