Clinical trial NCT01359813: Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis
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 ®)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cirrhosis
Sepsis
Renal Failure
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-05-25
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Renal failure rate
timeFrame: at 3 months
Secondary outcomes:
measure: In-hospital and at 3-month mortality
timeFrame: during hospitalization and 3-month mortality
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Angers
country: France
facility: CHU
city: Belfort
country: France
facility: CHBM
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Bordeaux
country: France
facility: CHU
city: Brest
country: France
facility: CHU
city: Caen
country: France
facility: CHU
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier universitaire
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: CHIC
city: Dijon
country: France
facility: CHU
city: Dunkerque
country: France
facility: Centre Hospitalier
city: Evry
country: France
facility: CH Francilien
city: Gonesse
country: France
facility: CH
city: Grenoble
country: France
facility: CHU
city: Lens
country: France
facility: CH
city: Lille
country: France
facility: CHU
city: Marseille
country: France
facility: Centre Hospitalier Universitaire
city: Maubeuge
country: France
facility: Centre Hospitalier
city: Nancy
country: France
facility: Centre Hospitalier Universitaire
city: Nice
country: France
facility: CHU
city: Orléans
country: France
facility: CHR
city: Paris
country: France
facility: CHU Tenon
city: Paris
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Pau
country: France
facility: CHU
city: Reims
country: France
facility: CHU
city: Rouen
country: France
facility: CHU
city: Saint Brieuc
country: France
facility: CH
city: Toulouse
country: France
facility: CHU
city: Tourcoing
country: France
facility: CH
city: Tours
country: France
facility: Centre Hospitalier régional Universitaire
city: Vesoul
country: France
facility: Centre Hospitalier
Study officials:
affiliation: CHU de Besançon
name: Thierry Thevenot, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.