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.
* 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
193
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.
CHU
Amiens, France
CHU
Angers, France
CHBM
Belfort, France
Centre Hospitalier Universitaire de Besançon
Besançon, France
Hôpital Jean Verdier
Bondy, France
CHU
Bordeaux, France
CHU
Brest, France
CHU
Caen, France
Hôpital Antoine Béclère
Clamart, France
Centre Hospitalier universitaire
Clermont-Ferrand, France
...and 25 more locations
Renal failure rate
Occurrence or deterioration of renal failure at 3 months
Time frame: at 3 months
In-hospital and at 3-month mortality
Time frame: during hospitalization and 3-month mortality
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