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decision of independent monitoring committee:Risk of death at 3 months higher in Albumin group than in control group, without reaching significance level.
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual treatment | No Intervention | intravenous injection of Human Albumin. 1,5g/kg on first day and 1g/kg on third day | |
| Human Albumin | Experimental | 1,5g/kg on first day and 1g/kg on third day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Albumin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal failure rate | Occurrence or deterioration of renal failure at 3 months | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital and at 3-month mortality | during hospitalization and 3-month mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Thevenot, PH | CHU de Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Amiens | 80054 | France | |||
| CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25463545 | Derived | 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. |
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| Angers |
| 49933 |
| France |
| CHBM | Belfort | 90016 | France |
| Centre Hospitalier Universitaire de Besançon | Besançon | 25000 | France |
| Hôpital 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 |
| Hôpital Beaujon | Clichy | 92110 | France |
| CHIC | Créteil | 94010 | France |
| CHU | Dijon | 21079 | France |
| Centre Hospitalier | Dunkirk | 59385 | France |
| CH Francilien | Évry | 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 |
| Hôpital Henri Mondor | Paris | 94010 | France |
| Hôpital 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 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D018805 | Sepsis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
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