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

This study has been terminated.
(decision of independent monitoring committee:Risk of death at 3 months higher in Albumin group than in control group, without reaching significance level.)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01359813
First received: May 23, 2011
Last updated: May 12, 2014
Last verified: July 2010
  Purpose

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.


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:


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 ]

Enrollment: 193
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual treatment
intravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day
Experimental: Human Albumin
1,5g/kg on first day and 1g/kg on third day.
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.

Detailed 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359813

Locations
France
CHU
Amiens, France, 80054
CHU
Angers, France, 49933
CHBM
Belfort, France, 90016
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25000
Hôpital Jean Verdier
Bondy, France, 93143
CHU
Bordeaux, France, 33404
CHU
Brest, France, 29609
CHU
Caen, France, 14033
Hôpital Antoine Béclère
Clamart, France, 92141
Centre Hospitalier universitaire
Clermont-Ferrand, France, 63003
Hôpital Beaujon
Clichy, France, 92110
CHIC
Créteil, France, 94010
CHU
Dijon, France, 21079
Centre Hospitalier
Dunkerque, France, 59385
CH Francilien
Evry, France, 91014
CH
Gonesse, France, 95300
CHU
Grenoble, France, 38043
CH
Lens, France, 62307
CHU
Lille, France, 59037
Centre Hospitalier Universitaire
Marseille, France, 13354
Centre Hospitalier
Maubeuge, France, 59607
Centre Hospitalier Universitaire
Nancy, France, 54035
CHU
Nice, France, 06003
CHR
Orléans, France, 45032
CHU Tenon
Paris, France, 75020
Hôpital Saint Antoine
Paris, France
Hôpital Henri Mondor
Paris, France, 94010
CHU
Pau, France, 64046
CHU
Reims, France, 51092
CHU
Rouen, France, 76031
CH
Saint Brieuc, France, 22027
CHU
Toulouse, France, 31059
CH
Tourcoing, France, 59208
Centre Hospitalier régional Universitaire
Tours, France, 37044
Centre Hospitalier
Vesoul, France, 70014
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: 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 12, 2014
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 July 24, 2014