Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"

This study is currently recruiting participants.
Verified November 2012 by Instituto Grifols, S.A.
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by:
Instituto Grifols, S.A.
ClinicalTrials.gov Identifier:
NCT01201720
First received: August 27, 2010
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".


Condition Intervention Phase
Liver Cirrhosis
Liver Failure
Procedure: Plasma exchange with albumin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Instituto Grifols, S.A.:

Primary Outcome Measures:
  • Albumin functional capacity [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Albumin binding capacity

  • Albumin functional capacity [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Electron Paramagnetic Resonance Spectroscopy

  • Albumin functional capacity [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Ischemia-modified albumin

  • Circulatory disfunction [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Plasma renin activity

  • Circulatory disfunction [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Plasma concentration of noradrenaline

  • Circulatory disfunction [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    Systemic hemodynamic study and portal venous pressure


Secondary Outcome Measures:
  • Plasma concentration of blood urea nitrogen [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Hepatic encephalopathy graded with the West Haven Criteria [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Hepatic function parameters [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Conventional hepatic function parameters: aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, alkaline phosphatase, total, conjugated and not conjugated serum bilirubin, serum albumin, international normalized ratio (INR) and prothrombin index

  • Plasma concentration of serum creatinine [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Plasma concentration of sodium [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Plasma concentration of potassium [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Plasma concentration of phosphorus [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • hepatic toxins [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.


Estimated Enrollment: 10
Study Start Date: March 2011
Arms Assigned Interventions
Experimental: Albumin Procedure: Plasma exchange with albumin
Realization of 6 plasma exchange with albumin in 11 days and administration of polyclonal gamma globulin.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years old
  • Hepatic cirrhosis diagnosed by biopsy or clinical, analytic and ultra sound data.
  • acute on chronic liver failure: defined by an acute deterioration in hepatic function produced in 2-4 weeks with jaundice (total serum bilirubin ≥ 5 mg/dl ) and hepatic encephalopathy (≥ grade 2) and/or renal insufficiency (serum creatinine ≥ 2 mg/dl)

Exclusion Criteria:

  • Neoplasm disease including hepatocarcinoma which exceed Milan criteria (1 tumour > 5cm, up to 3 tumours <3 cm)
  • Active bacterial or fungal infection with hemodynamic instability which require the utilization of vasoactive drugs at moderate dose (>0,5 μg/Kg/min of noradrenaline)
  • Structural moderate to severe cardiopathy (Cardiac Index <2l/min/m2)
  • Chronic renal insufficiency in treatment with haemodialysis
  • Chronic moderate o severe pulmonary disease (maximum expiratory volume in a second <50%)
  • Active transplant
  • human immunodeficiency virus infection
  • Pregnancy or lactation
  • Acute respiratory distress syndrome (P02/Fi02< 200mm Hg) or acute lung injury (P02/Fi02< 300mm Hg)
  • Hemodynamic instability (>0,5 μg/Kg/min of noradrenaline)
  • Bleeding in the digestive tract in the previous 72h to the treatment
  • Severe coagulopathy: INR ≥ 3.0 (Quick ≤ 20%) and/or platelets < 30000//mm3
  • Extrahepatic cholestasis
  • Hepatobiliary surgery in the last 6 months (except laparoscopic Cholecystectomy)
  • Concentrations bilirubin ≥ 5mg/dl during the period above 4 weeks previous to inclusion
  • Concomitant participation in an other clinical trial
  • Drug addiction
  • Mental status which does not allow the patient to understand the trial, with the exception of hepatic encephalopathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201720

Contacts
Contact: Ana Cruceta +34932275400 ext 9838 acruceta@clinic.ub.es

Locations
Spain
Hospital Clínic of Barcelona Recruiting
Barcelona, Spain, 08028
Principal Investigator: Vicente Arroyo, MD         
Sponsors and Collaborators
Instituto Grifols, S.A.
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Vicente Arroyo, MD Hospital Clínic of Barcelona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01201720     History of Changes
Other Study ID Numbers: IG0905
Study First Received: August 27, 2010
Last Updated: November 7, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Instituto Grifols, S.A.:
cirrhosis
cirrhotic patients with acute on chronic liver failure

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Failure
End Stage Liver Disease
Liver Diseases
Digestive System Diseases
Pathologic Processes
Hepatic Insufficiency

ClinicalTrials.gov processed this record on April 15, 2014