Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis (ALB-CIRINF)

Centre Hospitalier Universitaire de Besancon

Status and phase

Terminated

Phase 3

Conditions

Renal Failure

Cirrhosis

Sepsis

Treatments

Drug: Human Albumin

Study type

Interventional

Funder types

Other

Identifiers

NCT01359813

N/2008/51

Details and patient eligibility

About

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.

Full 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

Enrollment

193 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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