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

Sepsis Clinical Trial

— ALB-CIRINF  

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 ®)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01359813
• Other study ID #: N/2008/51
• Status: Terminated
• Phase: Phase 3
• First received: May 23, 2011
• Last updated: May 12, 2014
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2010
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 193
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Peritonitis
• Renal Failure
• Sepsis
• Systemic Inflammatory Response Syndrome

Intervention

Drug:
• Human Albumin
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.

Locations

Country	Name	City	State
France	CHU	Amiens
France	CHU	Angers
France	CHBM	Belfort
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	Hôpital Jean Verdier	Bondy
France	CHU	Bordeaux
France	CHU	Brest
France	CHU	Caen
France	Hôpital Antoine Béclère	Clamart
France	Centre Hospitalier universitaire	Clermont-Ferrand
France	Hôpital Beaujon	Clichy
France	CHIC	Créteil
France	CHU	Dijon
France	Centre Hospitalier	Dunkerque
France	CH Francilien	Evry
France	CH	Gonesse
France	CHU	Grenoble
France	CH	Lens
France	CHU	Lille
France	Centre Hospitalier Universitaire	Marseille
France	Centre Hospitalier	Maubeuge
France	Centre Hospitalier Universitaire	Nancy
France	CHU	Nice
France	CHR	Orléans
France	CHU Tenon	Paris
France	Hôpital Henri Mondor	Paris
France	Hôpital Saint Antoine	Paris
France	CHU	Pau
France	CHU	Reims
France	CHU	Rouen
France	CH	Saint Brieuc
France	CHU	Toulouse
France	CH	Tourcoing
France	Centre Hospitalier régional Universitaire	Tours
France	Centre Hospitalier	Vesoul

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal failure rate	Occurrence or deterioration of renal failure at 3 months	at 3 months	No
Secondary	In-hospital and at 3-month mortality		during hospitalization and 3-month mortality	No