Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe
circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal
failure is an important prognostic marker, representing the major predictive factor of
in-hospital mortality.
Recent studies have shown that plasma volume expansion with albumin associated with
cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime
treatment alone. The in-hospital and three-month mortality rates, furthermore, were
significantly lower in the group treated with albumin.
It is not known if other bacterial infections unrelated to SBP represent a risk factor for
the development of renal failure among cirrhotic patients. The researcher's group has
recently performed a study to evaluate the incidence, characteristics and outcome, of renal
failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with
the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of
106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure
was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/-
0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important
activation of endogenous vasoconstriction systems. The three-month survival probability of
patients with infection and renal failure was 34 %, much lower than that of patients with
infection but not presenting renal failure (87%, p<0.0001). These results suggest that the
development of renal failure in patients with cirrhosis and bacterial infections different
from SBP, associated with signs of a systemic inflammatory response, is very frequent and
results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to
consider these patients as candidates for liver transplantation and to plan strategies for
its prevention.
The objective of this project, therefore, is to evaluate if the plasma volume expansion with
albumin, associated with conventional antibiotic therapy, can prevent the development of
renal failure and increase survival rates in cirrhotic patients with bacterial infections
unrelated to spontaneous bacterial peritonitis.