We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201720
First Posted: September 15, 2010
Last Update Posted: June 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Joan Albert Arnaiz, Instituto Grifols, S.A.
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure"

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Albumin functional capacity [ Time Frame: 10 days ]
    Albumin binding capacity

  • Albumin functional capacity [ Time Frame: 10 days ]
    Electron Paramagnetic Resonance Spectroscopy

  • Albumin functional capacity [ Time Frame: 10 days ]
    Ischemia-modified albumin

  • Circulatory disfunction [ Time Frame: 10 days ]
    Plasma renin activity

  • Circulatory disfunction [ Time Frame: 10 days ]
    Plasma concentration of noradrenaline

  • Circulatory disfunction [ Time Frame: 11 days ]
    Systemic hemodynamic study and portal venous pressure


Secondary Outcome Measures:
  • Plasma concentration of blood urea nitrogen [ Time Frame: 1 month ]
  • Hepatic encephalopathy graded with the West Haven Criteria [ Time Frame: 1 month ]
  • Hepatic function parameters [ Time Frame: 1 month ]
    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 ]
  • Plasma concentration of sodium [ Time Frame: 1 month ]
  • Plasma concentration of potassium [ Time Frame: 1 month ]
  • Plasma concentration of phosphorus [ Time Frame: 1 month ]
  • hepatic toxins [ Time Frame: 10 days ]
    Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.


Enrollment: 12
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Albumin
Albumin solution for infusion 5%. dosage: 43,5 millimole intravenouse use , 6 plasma exchange with albumin in 11 days and administration of polyclonal gamma globulin.6 sessions
Procedure: Plasma exchange with albumin
Realization of 6 plasma exchange with albumin in 11 days
Other Name: Albumina grifols 5%

Detailed Description:
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", renal disfunction, cerebral disfunction ,and inflamtory response
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01201720


Locations
Spain
Hospital Clínic of Barcelona
Barcelona, Spain, 08028
Sponsors and Collaborators
Joan Albert Arnaiz
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Vicente Arroyo, MD Hospital Clínic of Barcelona
  More Information

Responsible Party: Joan Albert Arnaiz, CLINICAL TRIAL COORDINATOR, Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT01201720     History of Changes
Other Study ID Numbers: IG0905
2010-021360-15 ( EudraCT Number )
First Submitted: August 27, 2010
First Posted: September 15, 2010
Last Update Posted: June 17, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Failure, Acute