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Completed

NCT Number: NCT01201720

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"

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".

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic of Barcelona

Barcelona, 08028, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma exchange with albumin

Procedure

Realization of 6 plasma exchange with albumin in 11 days

Other names: Albumina grifols 5%

Primary outcomes

  1. Albumin functional capacity

    Time frame: 10 days

    Albumin binding capacity

  2. Albumin functional capacity

    Time frame: 10 days

    Electron Paramagnetic Resonance Spectroscopy

  3. Albumin functional capacity

    Time frame: 10 days

    Ischemia-modified albumin

  4. Circulatory disfunction

    Time frame: 10 days

    Plasma renin activity

  5. Circulatory disfunction

    Time frame: 10 days

    Plasma concentration of noradrenaline

  6. Circulatory disfunction

    Time frame: 11 days

    Systemic hemodynamic study and portal venous pressure

Secondary outcomes

  1. Plasma concentration of blood urea nitrogen

    Time frame: 1 month

  2. Hepatic encephalopathy graded with the West Haven Criteria

    Time frame: 1 month

  3. 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

  4. Plasma concentration of serum creatinine

    Time frame: 1 month

  5. Plasma concentration of sodium

    Time frame: 1 month

  6. Plasma concentration of potassium

    Time frame: 1 month

  7. Plasma concentration of phosphorus

    Time frame: 1 month

  8. hepatic toxins

    Time frame: 10 days

    Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.

Sponsors and collaborators

Lead sponsor

Instituto Grifols, S.A.

Industry

Registry information

Official study title

Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure"

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2010
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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