Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis
Information source: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Sepsis; Renal Failure
Intervention: Human Albumin (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Centre Hospitalier Universitaire de Besancon Official(s) and/or principal investigator(s):
Thierry Thevenot, PH, Principal Investigator, Affiliation: CHU de Besançon
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Renal failure rate
Secondary outcome: In-hospital and at 3-month mortality
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
CHU, Amiens 80054, France
CHU, Angers 49933, France
CHBM, Belfort 90016, France
Centre Hospitalier Universitaire de Besançon, Besançon 25000, France
HĂ´pital Jean Verdier, Bondy 93143, France
CHU, Bordeaux 33404, France
CHU, Brest 29609, France
CHU, Caen 14033, France
Hôpital Antoine Béclère, Clamart 92141, France
Centre Hospitalier universitaire, Clermont-Ferrand 63003, France
HĂ´pital Beaujon, Clichy 92110, France
CHIC, Créteil 94010, France
CHU, Dijon 21079, France
Centre Hospitalier, Dunkerque 59385, France
CH Francilien, Evry 91014, France
CH, Gonesse 95300, France
CHU, Grenoble 38043, France
CH, Lens 62307, France
CHU, Lille 59037, France
Centre Hospitalier Universitaire, Marseille 13354, France
Centre Hospitalier, Maubeuge 59607, France
Centre Hospitalier Universitaire, Nancy 54035, France
CHU, Nice 06003, France
CHR, Orléans 45032, France
CHU Tenon, Paris 75020, France
HĂ´pital Henri Mondor, Paris 94010, France
HĂ´pital Saint Antoine, Paris, France
CHU, Pau 64046, France
CHU, Reims 51092, France
CHU, Rouen 76031, France
CH, Saint Brieuc 22027, France
CHU, Toulouse 31059, France
CH, Tourcoing 59208, France
Centre Hospitalier régional Universitaire, Tours 37044, France
Centre Hospitalier, Vesoul 70014, France
Additional Information
Starting date: December 2008
Last updated: May 12, 2014
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