Hepatic EncephalopathyPhase 4ALFAENCT00886925
Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis
A Phase 4 study testing Albumin and Sodium chloride 0.9% in people with Hepatic Encephalopathy, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
Trial summary
The purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Albumin and Sodium chloride 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesSpain
- Study dates
- Mar 2009to Jul 2012
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis of the liver
- Hepatic encephalopathy stage>1
- Completion of a standardized protocol to investigate precipitating factors
- Informed consent by next of keen
Who cannot join
- Pregnancy
- Terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy)
- Need of advanced life support (mechanical ventilation, ionotropic support, dialysis)
- Need of albumin administration (e.g. bacterial spontaneous peritonitis)
- Contraindication for albumin administration (e.g. cardiac failure)
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital de Sant Pau
Barcelona, 08025
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic
Barcelona, 08036
Parc Tauli
Sabadell, Barcelona
About this study
Official title: Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.
The purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.
Read the detailed description
Hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated with poor prognosis. The most common presentation is an acute episode of hepatic encephalopathy precipitated by factors that increase the exposure of the brain to ammonia. Current therapies are based on measures that decrease plasma ammonia and counteract the effect of factors such as infection or electrolyte's disturbances. Brain edema and abnormalities of cerebral blood flow appear to be important. Part of the impairment of astrocyte function could be related to an increase of oxidative stress injury.
In patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma is usually low. Administration of human albumin in patients with hepatorenal syndrome and spontaneous bacterial peritonitis has a major impact on the prognosis of these complications. Albumin prevents circulatory dysfunction and renal failure. The mechanisms of action may include the maintenance of oncotic pressure and a scavenger effect of toxic substances present in blood. Albumin has also shown beneficial effects in neurological injury secondary to stroke, probably in relation to this scavenger effect.
The administration of intravenous albumin to patients with hepatic encephalopathy may have beneficial effects on the course of encephalopathy.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Albumin, Sodium chloride 0.9%
- Keywords
- Hepatic encephalopathy, Cirrhosis, Albumin
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
Sodium chloride 0.9%Drug
Day 0: 400-600 ml. Day 2: 200-400 ml.
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Active comparator | Not described Receives: Drug: Albumin |
| Saline | Placebo comparator | Not described Receives: Drug: Sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without hepatic encephalopathy
Measured: Day 3
Secondary outcomes (1)
Severity of encephalopathy assessed by CHESS and West-Haven
Measured: Admission to the hospital (up to day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2012
- Study completionJul 2012
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 Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Cordoba, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886925
- Sponsor's protocol ID
- ALFAE
- Other IDs
- 2008-003376-21, PI07 - 0641, 2008
- Acronym
- ALFAE
- Status last verified
- Apr 2012
- First submitted
- 22 Apr 2009
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.
PubMed 23872605
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.
- ClinicalTrials.gov ID
- NCT00886925
- Acronym / sponsor ID
- ALFAE / ALFAE
- Conditions
- Hepatic Encephalopathy
- Keywords
- Hepatic encephalopathy, Cirrhosis, Albumin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Apr 2009 (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 determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.
Detailed description
Hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated with poor prognosis. The most common presentation is an acute episode of hepatic encephalopathy precipitated by factors that increase the exposure of the brain to ammonia. Current therapies are based on measures that decrease plasma ammonia and counteract the effect of factors such as infection or electrolyte's disturbances. Brain edema and abnormalities of cerebral blood flow appear to be important. Part of the impairment of astrocyte function could be related to an increase of oxidative stress injury.
In patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma is usually low. Administration of human albumin in patients with hepatorenal syndrome and spontaneous bacterial peritonitis has a major impact on the prognosis of these complications. Albumin prevents circulatory dysfunction and renal failure. The mechanisms of action may include the maintenance of oncotic pressure and a scavenger effect of toxic substances present in blood. Albumin has also shown beneficial effects in neurological injury secondary to stroke, probably in relation to this scavenger effect.
The administration of intravenous albumin to patients with hepatic encephalopathy may have beneficial effects on the course of encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Active comparator | Drug: Albumin |
| Saline | Placebo comparator | Drug: Sodium chloride 0.9% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis of the liver
- Hepatic encephalopathy stage>1
- Completion of a standardized protocol to investigate precipitating factors
- Informed consent by next of keen
Key exclusion criteria (5 listed)
- Pregnancy
- Terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy)
- Need of advanced life support (mechanical ventilation, ionotropic support, dialysis)
- Need of albumin administration (e.g. bacterial spontaneous peritonitis)
- Contraindication for albumin administration (e.g. cardiac failure)
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 |
|---|---|---|
| AlbuminAlbumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml. | Drug | Albumin |
| Sodium chloride 0.9%Day 0: 400-600 ml. Day 2: 200-400 ml. | Drug | Saline |
Primary outcome
Proportion of patients without hepatic encephalopathy
Time frame: Day 3
1 secondary outcome
Severity of encephalopathy assessed by CHESS and West-Haven
Time frame: Admission to the hospital (up to day 14)
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 17 Dec 2012.
- Derived from this study: PubMed 23872605Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.
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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.
Juan Cordoba, MD principal investigator
Hospital Vall d'Hebron
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albumin and Sodium chloride 0.9% in people with Hepatic Encephalopathy, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites 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 4 inclusion and 5 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients without hepatic encephalopathy (time frame: Day 3). 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 NCT00886925, 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 17 Dec 2012.