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"

NCT01201720 | Completed

• 2 other identifiers: IG09052010-021360-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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".

Conditions

Liver Cirrhosis; Liver Failure

Keywords

cirrhosis; cirrhotic patients with acute on chronic liver failure

Outcome Measures

Primary Outcomes (6)

• Albumin functional capacity

  Albumin binding capacity

  10 days

• Albumin functional capacity

  Electron Paramagnetic Resonance Spectroscopy

  10 days

• Albumin functional capacity

  Ischemia-modified albumin

  10 days

• Circulatory disfunction

  Plasma renin activity

  10 days

• Circulatory disfunction

  Plasma concentration of noradrenaline

  10 days

• Circulatory disfunction

  Systemic hemodynamic study and portal venous pressure

  11 days

Secondary Outcomes (8)

• Plasma concentration of blood urea nitrogen

  1 month

• Hepatic encephalopathy graded with the West Haven Criteria

  1 month

• Hepatic function parameters

  1 month

• Plasma concentration of serum creatinine

  1 month

• Plasma concentration of sodium

  1 month

Study Arms (1)

Albumin

OTHER

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

Interventions

Plasma exchange with albumin PROCEDURE

Realization of 6 plasma exchange with albumin in 11 days

Also known as: Albumina grifols 5%

Albumin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Concomitant participation in an other clinical trial

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (1)

Hospital Clínic of Barcelona

Barcelona, 08028, Spain

Location

Related Publications (1)

• Fernandez J, Lozano M, Torres M, Horrillo R, Afonso N, Nunez L, Mestre A, Perez A, Cid J, Costa M, Arroyo V, Paez A. Effect of plasma exchange with albumin replacement on albumin functionality and organ dysfunction in acute-on-chronic liver failure. JHEP Rep. 2024 Jan 22;6(4):101017. doi: 10.1016/j.jhepr.2024.101017. eCollection 2024 Apr.

  PMID: 38544553 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Liver Failure; Fibrosis

Interventions

Plasma Exchange; Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Vicente Arroyo, MD

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: September 15, 2010
• Study Start: March 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

ES (1)