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CirrhosisPhase 3ALB-CIRINFNCT01359813

Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis

A Phase 3 study testing Human Albumin in people with Cirrhosis and Sepsis, run by Centre Hospitalier Universitaire de Besancon at 35 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cirrhosis, Sepsis, Renal Failure
What is being tested?
Human Albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
35 sitesFrance
Study dates
Dec 2008to Jun 2012
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cirrhosis defined by clinical, laboratory or ultrasonographic findings
  • Child-Pugh > 8
  • Sepsis defined by the presence of proved or suspected infection with two of the four SIRS (systemic inflammatory response syndrome) criteria (Wong F, et al. Sepsis in cirrhosis: report on the 7th meeting of the international ascites club. Gut 2005)
  • Creatinine < 160 µmol/L
  • Written informed consent
  • Absence of the exclusion criteria

Who cannot join

  • Spontaneous bacterial peritonitis
  • Difficult to treat infections such as : endocarditis, septic arthritis, osteomyelitis
  • Heart insufficiency (YHA III-IV)
  • Digestive bleeding during the week preceding the study
  • Septic shock
  • Hepatocellular carcinoma : stage D
  • Use of antibiotics during the week preceding the study, except noroxin used for long-term antibioprophylaxy
  • Diseases which can influence the short term survival

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

France35 sites

  • CHU

    Amiens, 80054

  • CHU

    Angers, 49933

  • CHBM

    Belfort, 90016

  • Centre Hospitalier Universitaire de Besançon

    Besançon, 25000

  • Hôpital Jean Verdier

    Bondy, 93143

  • CHU

    Bordeaux, 33404

  • CHU

    Brest, 29609

  • CHU

    Caen, 14033

  • Hôpital Antoine Béclère

    Clamart, 92141

  • Centre Hospitalier universitaire

    Clermont-Ferrand, 63003

  • Hôpital Beaujon

    Clichy, 92110

  • CHIC

    Créteil, 94010

  • CHU

    Dijon, 21079

  • Centre Hospitalier

    Dunkirk, 59385

  • CH Francilien

    Évry, 91014

  • CH

    Gonesse, 95300

  • CHU

    Grenoble, 38043

  • CH

    Lens, 62307

  • CHU

    Lille, 59037

  • Centre Hospitalier Universitaire

    Marseille, 13354

  • Centre Hospitalier

    Maubeuge, 59607

  • Centre Hospitalier Universitaire

    Nancy, 54035

  • CHU

    Nice, 06003

  • CHR

    Orléans, 45032

  • CHU Tenon

    Paris, 75020

  • Hôpital Henri Mondor

    Paris, 94010

  • Hôpital Saint Antoine

    Paris

  • CHU

    Pau, 64046

  • CHU

    Reims, 51092

  • CHU

    Rouen, 76031

  • CH

    Saint-Brieuc, 22027

  • CHU

    Toulouse, 31059

  • CH

    Tourcoing, 59208

  • Centre Hospitalier régional Universitaire

    Tours, 37044

  • Centre Hospitalier

    Vesoul, 70014

Other trials in France

About this study

Official title: Effects of Albumin Administration in Septic Cirrhotic Patients With Child > 8 Unrelated to Spontaneous Bacterial Peritonitis on Renal Function and Survival: A Multicenter Randomized Controlled Trial Comparing Use and Non-use of Human Albumin (Vialebex ®)

Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However, little is known regarding the effect of albumin administration in patients with non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are associated with impairment of the effective circulating volume and precipitate renal failure whatever the presence of ascites.

The aim of this randomized clinical trial is to evaluate the effects of albumin, associated with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and presenting with a Child-Pugh score > 8.

Read the detailed description
  • Cirrhosis defined by clinical, laboratory or ultrasonographic findings
  • Child-Pugh > 8
  • Sepsis defined by the presence of proved or suspected infection with two of the four SIRS (systemic inflammatory response syndrome) criteria (Wong F, et al. Sepsis in cirrhosis: report on the 7th meeting of the international ascites club. Gut 2005)
  • Creatinine < 160 µmol/L
Being tested
Human Albumin
Medical subject headings
Fibrosis, Sepsis, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human AlbuminDrug

    Administration: 1,5 g/kg at Day 1 and 1g/kg at Day 3 In case of a new infection appears in the 3 months, the same doses will be administrated.

Study groups in NCT01359813
Study groupRoleWhat they receive
Usual treatmentNo interventionintravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day
Human AlbuminExperimental1,5g/kg on first day and 1g/kg on third day.
Receives: Drug: Human Albumin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal failure rate

    Occurrence or deterioration of renal failure at 3 months

    Measured: at 3 months

Secondary outcomes (1)

  1. In-hospital and at 3-month mortality

    Measured: during hospitalization and 3-month mortality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2011 (estimated)
  2. Study startDec 2008
  3. Primary completionSep 2011
  4. Study completionJun 2012

Why it stopped: decision of independent monitoring committee:Risk of death at 3 months higher in Albumin group than in control group, without reaching significance level.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01359813
Sponsor's protocol ID
N/2008/51
Acronym
ALB-CIRINF
Status last verified
Jul 2010
First submitted
23 May 2011
Last updated
13 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Thevenot T, Bureau C, Oberti F, Anty R, Louvet A, Plessier A, Rudler M, Heurgue-Berlot A, Rosa I, Talbodec N, Dao T, Ozenne V, Carbonell N, Causse X, Goria O, Minello A, De Ledinghen V, Amathieu R, Barraud H, Nguyen-Khac E, Becker C, Paupard T, Botta-Fridlung D, Abdelli N, Guillemot F, Monnet E, Di Martino V. Effect of albumin in cirrhotic patients with infection other than spontaneous bacterial peritonitis. A randomized trial. J Hepatol. 2015 Apr;62(4):822-30. doi: 10.1016/j.jhep.2014.11.017. Epub 2014 Nov 21.

    PubMed 25463545

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human Albumin in people with Cirrhosis and Sepsis, run by Centre Hospitalier Universitaire de Besancon at 35 sites in France.

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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: decision of independent monitoring committee:Risk of death at 3 months higher in Albumin group than in control group, without reaching significance level.). Results are not available in the source record.

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?

Renal failure rate (time frame: at 3 months). 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 NCT01359813, 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 13 May 2014.

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