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"

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201720
• Other study ID #: IG0905
• Secondary ID: 2010-021360-15
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2019
• Source: Grifols Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Fibrosis
• Hepatic Insufficiency
• Liver Cirrhosis
• Liver Failure

Intervention

Procedure:
• Plasma exchange with albumin
Realization of 6 plasma exchange with albumin in 11 days

Locations

Country	Name	City	State
Spain	Hospital Clínic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Albumin functional capacity	Albumin binding capacity	10 days
Primary	Albumin functional capacity	Electron Paramagnetic Resonance Spectroscopy	10 days
Primary	Albumin functional capacity	Ischemia-modified albumin	10 days
Primary	Circulatory disfunction	Plasma renin activity	10 days
Primary	Circulatory disfunction	Plasma concentration of noradrenaline	10 days
Primary	Circulatory disfunction	Systemic hemodynamic study and portal venous pressure	11 days
Secondary	Plasma concentration of blood urea nitrogen		1 month
Secondary	Hepatic encephalopathy graded with the West Haven Criteria		1 month
Secondary	Hepatic function parameters	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	1 month
Secondary	Plasma concentration of serum creatinine		1 month
Secondary	Plasma concentration of sodium		1 month
Secondary	Plasma concentration of potassium		1 month
Secondary	Plasma concentration of phosphorus		1 month
Secondary	hepatic toxins	Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.	10 days