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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01359813
First received: May 23, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis 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.


Condition Intervention Phase
Cirrhosis
Sepsis
Renal Failure
 Drug: Human Albumin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ®)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • Renal failure rate [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    Occurrence or deterioration of renal failure at 3 months


Secondary Outcome Measures:
  • In-hospital and at 3-month mortality [ Time Frame: during hospitalization and 3-month mortality ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: December 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual treatment
Experimental: Human Albumin 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359813

Contacts
Contact: Thierry THEVENOT, PH 0033 (0)3 81 66 81 11 tthevenot@chu-besancon.fr

Locations
France
CHU Recruiting
Amiens, France, 80054
Contact: Eric NGUYEN-KHAC            
Principal Investigator: Eric NGUYEN-KHAC            
CHU Recruiting
Angers, France, 49933
Contact: OBERTI            
Principal Investigator: OBERTI            
CHBM Not yet recruiting
Belfort, France, 90016
Contact: Serge FRATTE            
Principal Investigator: Serge FRATTE            
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France, 25000
Contact: Emilie MUEL     0033 (0)3 81 66 81 11     emuel@chu-besancon.fr    
Principal Investigator: Thierry THEVENOT            
Hôpital Jean Verdier Recruiting
Bondy, France, 93143
Contact: Roland AMATHIEU            
Principal Investigator: Roland AMATHIEU            
CHU Not yet recruiting
Bordeaux, France, 33404
Contact: Victor DE-LEDINGHEN            
Principal Investigator: Victor DE-LEDINGHEN            
CHU Not yet recruiting
Brest, France, 29609
Contact: Jean Baptiste NOUSBAUM            
Principal Investigator: Jean-Baptiste NOUSBAUM            
CHU Recruiting
Caen, France, 14033
Contact: T. DAO            
Principal Investigator: T. DAO            
Hôpital Antoine Béclère Not yet recruiting
Clamart, France, 92141
Contact: Sylvie NAVEAU            
Principal Investigator: Sylvie NAVEAU            
Centre Hospitalier universitaire Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Armand ABERGEL            
Principal Investigator: Armand ABERGEL            
Hôpital Beaujon Recruiting
Clichy, France, 92110
Contact: Richard MOREAU            
Principal Investigator: Richard MOREAU            
CHIC Recruiting
Créteil, France, 94010
Contact: Isabelle ROSA            
Principal Investigator: Isabelle ROSA            
CHU Recruiting
Dijon, France, 21079
Contact: Anne MINELLO            
Principal Investigator: Anne MINELLO            
Centre Hospitalier Not yet recruiting
Dunkerque, France, 59385
Contact: Thierry PAUPARD            
Principal Investigator: Thierry PAUPARD            
CH Francilien Not yet recruiting
Evry, France, 91014
Contact: Jacques DENIS            
Principal Investigator: Jacques DENIS            
CH Not yet recruiting
Gonesse, France, 95300
Contact: Arnaud PAUWELS            
Principal Investigator: Arnaud PAUWELS            
CHU Not yet recruiting
Grenoble, France, 38043
Contact: Vincent LEROY            
Principal Investigator: Vincent LEROY            
CH Recruiting
Lens, France, 62307
Contact: Claire BECKER            
Principal Investigator: Claire BECKER            
CHU Recruiting
Lille, France, 59037
Contact: Philippe MATHURIN            
Principal Investigator: Philippe MATHURIN            
Centre Hospitalier Universitaire Recruiting
Marseille, France, 13354
Contact: Danielle BOTTA-FRIDLUNG            
Principal Investigator: Danielle BOTTA-FRIDLUNG            
Centre Hospitalier Not yet recruiting
Maubeuge, France, 59607
Contact: Nathalie BIRON            
Principal Investigator: Nathalie BIRON            
Centre Hospitalier Universitaire Recruiting
Nancy, France, 54035
Contact: JP BRONOWICKI            
Principal Investigator: JP BRONOWICKI            
CHU Recruiting
Nice, France, 06003
Contact: TRAN            
Principal Investigator: TRAN            
CHR Recruiting
Orléans, France, 45032
Contact: Xavier CAUSSE            
Principal Investigator: Xavier CAUSSE            
CHU Tenon Not yet recruiting
Paris, France, 75020
Contact: Jean-Didier GRANGE            
Principal Investigator: Jean-Didier GRANGE            
Hôpital Saint Antoine Not yet recruiting
Paris, France
Contact: Nicolas CARBONELL            
Principal Investigator: Nicolas CARBONELL            
Hôpital Henri Mondor Not yet recruiting
Paris, France, 94010
Contact: Ariane MALLAT            
Principal Investigator: Ariane MALLAT            
CHU Not yet recruiting
Pau, France, 64046
Contact: Ramuntcho AROTCARENA            
Principal Investigator: Ramuntcho AROTCARENA            
CHU Recruiting
Reims, France, 51092
Contact: Alexandra HEURGUE            
Principal Investigator: Alexandra HEURGUE            
CHU Recruiting
Rouen, France, 76031
Contact: Odile GORIA            
Principal Investigator: Odile GORIA            
CH Not yet recruiting
Saint Brieuc, France, 22027
Contact: Olivier NOUEL            
Principal Investigator: Olivier NOUEL            
CHU Recruiting
Toulouse, France, 31059
Contact: Jean Pierre VINEL            
Principal Investigator: Jean Pierre VINEL            
CH Recruiting
Tourcoing, France, 59208
Contact: Nathalie TALBODEC            
Principal Investigator: Nathalie TALBODEC            
Centre Hospitalier régional Universitaire Not yet recruiting
Tours, France, 37044
Contact: Louis D'ALTEROCHE            
Principal Investigator: Louis D'ALTEROCHE            
Centre Hospitalier Not yet recruiting
Vesoul, France, 70014
Contact: Simona TIRZIU            
Principal Investigator: Simona TIRZIU            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Ministry of Health, France
Investigators
Principal Investigator: Thierry Thevenot, PH CHU de Besançon
  More Information

No publications provided

Responsible Party: Dr Thierry THEVENOT, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01359813     History of Changes
Other Study ID Numbers: N/2008/51
Study First Received: May 23, 2011
Last Updated: May 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bacterial Infections
Liver Cirrhosis
Fibrosis
Peritonitis
Renal Insufficiency
Sepsis
Systemic Inflammatory Response Syndrome
Liver Diseases
 Digestive System Diseases
Pathologic Processes
Peritoneal Diseases
Kidney Diseases
Urologic Diseases
Infection
Inflammation
Shock

ClinicalTrials.gov processed this record on May 21, 2013