Liver CirrhosisNCT01201720
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"
A study testing Plasma exchange with albumin in people with Liver Cirrhosis and Liver Failure, run by Instituto Grifols, S.A. at 1 site in Spain.
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". Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Liver Failure
- What is being tested?
- Plasma exchange with albumin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory 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".
Read the 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
- Conditions
- Liver Cirrhosis, Liver Failure
- Being tested
- Plasma exchange with albumin
- Keywords
- cirrhosis, cirrhotic patients with acute on chronic liver failure
- Medical subject headings
- Liver Cirrhosis, Liver Failure, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchange with albuminProcedure or surgery
Also called Albumina grifols 5%
Realization of 6 plasma exchange with albumin in 11 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Plasma exchange with albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albumin functional capacity
Albumin binding capacity
Measured: 10 days
Albumin functional capacity
Electron Paramagnetic Resonance Spectroscopy
Measured: 10 days
Albumin functional capacity
Ischemia-modified albumin
Measured: 10 days
Circulatory disfunction
Plasma renin activity
Measured: 10 days
Circulatory disfunction
Plasma concentration of noradrenaline
Measured: 10 days
Circulatory disfunction
Systemic hemodynamic study and portal venous pressure
Measured: 11 days
Secondary outcomes (8)
Plasma concentration of blood urea nitrogen
Measured: 1 month
Hepatic encephalopathy graded with the West Haven Criteria
Measured: 1 month
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
Measured: 1 month
Plasma concentration of serum creatinine
Measured: 1 month
Plasma concentration of sodium
Measured: 1 month
Plasma concentration of potassium
Measured: 1 month
Plasma concentration of phosphorus
Measured: 1 month
hepatic toxins
Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicente Arroyo, MD, Principal investigator, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201720
- Sponsor's protocol ID
- IG0905
- Other IDs
- 2010-021360-15
- Status last verified
- Feb 2019
- First submitted
- 27 Aug 2010
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38544553
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure"
- ClinicalTrials.gov ID
- NCT01201720
- Acronym / sponsor ID
- IG0905
- Conditions
- Liver Cirrhosis, Liver Failure
- Keywords
- cirrhosis, cirrhotic patients with acute on chronic liver failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin | Other | Procedure: Plasma exchange with albuminAlbumin 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (18 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma exchange with albuminAlso: Albumina grifols 5%Realization of 6 plasma exchange with albumin in 11 days | Procedure or surgery | Albumin |
Primary outcome
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
8 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Derived from this study: PubMed 38544553Fernandez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Arroyo, MD principal investigator
Hospital Clínic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma exchange with albumin in people with Liver Cirrhosis and Liver Failure, run by Instituto Grifols, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albumin functional capacity (time frame: 10 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.