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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01359813
• Date of registration: 23/05/2011
• Primary sponsor: Centre Hospitalier Universitaire de Besancon
• Public title: Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis ALB-CIRINF
• Scientific 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 ®)
• Date of first enrolment: December 2008
• Target sample size: 206
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01359813
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Thierry THEVENOT, PH

• Name: Thierry Thevenot, PH
• Affiliation: CHU de Besançon

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cirrhosis

Renal Failure

Sepsis

Intervention(s)

Drug: Human Albumin

Primary Outcome(s)

Renal failure rate [Time Frame: at 3 months]

Secondary Outcome(s)

In-hospital and at 3-month mortality [Time Frame: during hospitalization and 3-month mortality]

Secondary ID(s)

N/2008/51

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, France