Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis

Study Overview
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Brief Summary
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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
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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

Official Title
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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 ®)

Conditions
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Cirrhosis, Sepsis, Renal Failure

Intervention / Treatment
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* Drug: Human Albumin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual treatment<br>intravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day | |
| Experimental: Human Albumin<br>1,5g/kg on first day and 1g/kg on third day. | Drug: Human Albumin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal failure rate | Occurrence or deterioration of renal failure at 3 months | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital and at 3-month mortality |  | during hospitalization and 3-month mortality |