Study Stopped
decision of independent monitoring committee:Risk of death at 3 months higher in Albumin group than in control group, without reaching significance level.
Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis
ALB-CIRINF
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 ®)
1 other identifier
interventional
193
1 country
35
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2008
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMay 13, 2014
July 1, 2010
2.8 years
May 23, 2011
May 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Renal failure rate
Occurrence or deterioration of renal failure at 3 months
at 3 months
Secondary Outcomes (1)
In-hospital and at 3-month mortality
during hospitalization and 3-month mortality
Study Arms (2)
Usual treatment
NO INTERVENTIONintravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day
Human Albumin
EXPERIMENTAL1,5g/kg on first day and 1g/kg on third day.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
CHU
Amiens, 80054, France
CHU
Angers, 49933, France
CHBM
Belfort, 90016, France
Centre Hospitalier Universitaire de Besançon
Besançon, 25000, France
Hôpital Jean Verdier
Bondy, 93143, France
CHU
Bordeaux, 33404, France
CHU
Brest, 29609, France
CHU
Caen, 14033, France
Hôpital Antoine Béclère
Clamart, 92141, France
Centre Hospitalier universitaire
Clermont-Ferrand, 63003, France
Hôpital Beaujon
Clichy, 92110, France
CHIC
Créteil, 94010, France
CHU
Dijon, 21079, France
Centre Hospitalier
Dunkirk, 59385, France
CH Francilien
Évry, 91014, France
CH
Gonesse, 95300, France
CHU
Grenoble, 38043, France
CH
Lens, 62307, France
CHU
Lille, 59037, France
Centre Hospitalier Universitaire
Marseille, 13354, France
Centre Hospitalier
Maubeuge, 59607, France
Centre Hospitalier Universitaire
Nancy, 54035, France
CHU
Nice, 06003, France
CHR
Orléans, 45032, France
CHU Tenon
Paris, 75020, France
Hôpital Henri Mondor
Paris, 94010, France
Hôpital Saint Antoine
Paris, France
CHU
Pau, 64046, France
CHU
Reims, 51092, France
CHU
Rouen, 76031, France
CH
Saint-Brieuc, 22027, France
CHU
Toulouse, 31059, France
CH
Tourcoing, 59208, France
Centre Hospitalier régional Universitaire
Tours, 37044, France
Centre Hospitalier
Vesoul, 70014, France
Related Publications (1)
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.
PMID: 25463545DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry Thevenot, PH
CHU de Besançon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 25, 2011
Study Start
December 1, 2008
Primary Completion
September 1, 2011
Study Completion
June 1, 2012
Last Updated
May 13, 2014
Record last verified: 2010-07