Sepsis Clinical Trial
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.
- 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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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