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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)

Primary Purpose

Cirrhosis, Sepsis, Renal Failure

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Human Albumin
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • CHU
  • CHBM
  • Centre Hospitalier Universitaire de Besançon
  • Hôpital Jean Verdier
  • CHU
  • CHU
  • CHU
  • Hôpital Antoine Béclère
  • Centre Hospitalier universitaire
  • Hôpital Beaujon
  • CHIC
  • CHU
  • Centre Hospitalier
  • CH Francilien
  • CH
  • CHU
  • CH
  • CHU
  • Centre Hospitalier Universitaire
  • Centre Hospitalier
  • Centre Hospitalier Universitaire
  • CHU
  • CHR
  • CHU Tenon
  • Hôpital Henri Mondor
  • Hôpital Saint Antoine
  • CHU
  • CHU
  • CHU
  • CH
  • CHU
  • CH
  • Centre Hospitalier régional Universitaire
  • Centre Hospitalier

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual treatment

Human Albumin

Arm Description

intravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day

1,5g/kg on first day and 1g/kg on third day.

Outcomes

Primary Outcome Measures

Renal failure rate
Occurrence or deterioration of renal failure at 3 months

Secondary Outcome Measures

In-hospital and at 3-month mortality

Full Information

First Posted
May 23, 2011
Last Updated
May 12, 2014
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01359813
Brief Title
Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis
Acronym
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 ®)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
decision of independent monitoring committee:Risk of death at 3 months higher in Albumin group than in control group, without reaching significance level.
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Sepsis, Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual treatment
Arm Type
No Intervention
Arm Description
intravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day
Arm Title
Human Albumin
Arm Type
Experimental
Arm Description
1,5g/kg on first day and 1g/kg on third day.
Intervention Type
Drug
Intervention Name(s)
Human Albumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Renal failure rate
Description
Occurrence or deterioration of renal failure at 3 months
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
In-hospital and at 3-month mortality
Time Frame
during hospitalization and 3-month mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Thevenot, PH
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHBM
City
Belfort
ZIP/Postal Code
90016
Country
France
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Hôpital Jean Verdier
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
CHU
City
Bordeaux
ZIP/Postal Code
33404
Country
France
Facility Name
CHU
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Centre Hospitalier universitaire
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHIC
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
CH Francilien
City
Evry
ZIP/Postal Code
91014
Country
France
Facility Name
CH
City
Gonesse
ZIP/Postal Code
95300
Country
France
Facility Name
CHU
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CH
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Name
Centre Hospitalier
City
Maubeuge
ZIP/Postal Code
59607
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
CHU
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Name
CHR
City
Orléans
ZIP/Postal Code
45032
Country
France
Facility Name
CHU Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Henri Mondor
City
Paris
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
CHU
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
CHU
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CH
City
Saint Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
CHU
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CH
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Centre Hospitalier régional Universitaire
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Hospitalier
City
Vesoul
ZIP/Postal Code
70014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25463545
Citation
Thevenot T, Bureau C, Oberti F, Anty R, Louvet A, Plessier A, Rudler M, Heurgue-Berlot A, Rosa I, Talbodec N, Dao T, Ozenne V, Carbonell N, Causse X, Goria O, Minello A, De Ledinghen V, Amathieu R, Barraud H, Nguyen-Khac E, Becker C, Paupard T, Botta-Fridlung D, Abdelli N, Guillemot F, Monnet E, Di Martino V. Effect of albumin in cirrhotic patients with infection other than spontaneous bacterial peritonitis. A randomized trial. J Hepatol. 2015 Apr;62(4):822-30. doi: 10.1016/j.jhep.2014.11.017. Epub 2014 Nov 21.
Results Reference
derived

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

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