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The purpose of this randomized, comparative, open and multi-centre study is to show that two sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from septic shock.
The mortality rate due to peritonitis associated to a severe sepsis or a septic shock remains high (between 40 and 60% as per the studies). The recent complementary therapies for severe sepsis have been reassessed (strict glycaemic control, substitutive corticotherapy, activated protein C). Early neutralisation of the endotoxaemia related to gram-negative bacilli sepsis in contact with hemoperfusion membrane covered with polymyxin B (Toraymyxin™) may enable reduction of the inflammatory reaction caused by sepsis and improve its prognosis. 30 studies, including 10 randomized studies, have compared hemoperfusion with Toraymyxin™ to the standard treatment, showing an improvement in the patients' haemodynamic state, oxygenation conditions and reduction in mortality. This treatment is commonly used in Japan. However, the studies conducted either include only a limited number of patients or are not randomized prospective studies. The post-hoc analysis of a recent randomized study conducted on a limited number of patients with abdominal septic shock shows a significant reduction in mortality after factor adjustment. Though the side effects of such a treatment are limited, its cost is high. Hence, extensive prospective studies are necessary to confirm its effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | Other | Standard therapy in the ICU including but not limited to: antibiotic therapy, nutrition, fluid challenge, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, renal replacement therapy when appropriate |
|
| Hemoperfusion | Experimental | standard therapy + 2 sessions of hemoperfusion within the first 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard therapy | Device | Standard therapy in the ICU including but not limited to: antibiotic therapy, nutrition, fluid challenge, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, renal replacement therapy when appropriate |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| organ failure assessed by SOFA score | day 3 | |
| delay to withdraw catecholamine after initial shock | day 1-day 28 | |
| mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Payen, MD | Lariboisière University Hospital | Principal Investigator |
| René Robert, MD | Poitiers University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont-Ferrand University Hospital | Clermont-Ferrand | 63058 | France | |||
| Dieppe Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25862039 | Derived | Payen DM, Guilhot J, Launey Y, Lukaszewicz AC, Kaaki M, Veber B, Pottecher J, Joannes-Boyau O, Martin-Lefevre L, Jabaudon M, Mimoz O, Coudroy R, Ferrandiere M, Kipnis E, Vela C, Chevallier S, Mallat J, Robert R; ABDOMIX Group. Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med. 2015 Jun;41(6):975-84. doi: 10.1007/s00134-015-3751-z. Epub 2015 Apr 11. |
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| hemoperfusion | Device | Extracorporeal hemoperfusion with Toraymyxin PMX-20R and conventional medical therapy in the ICU including but not limited to: antibiotic therapy, nutrition, fluid challenge, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, renal replacement therapy when appropriate. |
|
|
| 90 days |
| number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion) | day1-day4 |
| Dieppe |
| 76202 |
| France |
| Vendée Hospital | La Roche-sur-Yon | 85925 | France |
| Dr Schaffner Hospital | Lens | 62307 | France |
| Lille University Hospital | Lille | 59037 | France |
| Limoges University Hospital | Limoges | 87042 | France |
| La Source Hospital | Orléans | 45067 | France |
| Lariboisière University Hospital | Paris | 75010 | France |
| Saint Louis Hospital | Paris | 75475 | France |
| Saint Jean Hospital | Perpignan | 66046 | France |
| Bordeaux University Hospital | Pessac | 33600 | France |
| Poitiers University Hospital | Poitiers | 86021 | France |
| Pontchaillou University Hospital | Rennes | 35033 | France |
| Roanne Hospital | Roanne | 42300 | France |
| Rouen University Hospital | Rouen | 76031 | France |
| Saint-Malo Hospital | St-Malo | 35403 | France |
| Strasbourg University Hospital | Strasbourg | 67091 | France |
| Tours University Hospital | Tours | 37044 | France |
| ID | Term |
|---|---|
| D010538 | Peritonitis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D006464 | Hemoperfusion |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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