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:
Instituto Grifols, S.A.
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
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
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 May 16, 2013