Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock (ABDO-MIX)

Meditor

Status and phase: Completed; Phase 3

Conditions: Peritonitis; Septic Shock

Treatments: Device: standard therapy; Device: hemoperfusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222663

2010-67-PMX

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed community or nosocomial acquired peritonitis due to organ perforation
• Septic shock requiring catecholamine infusion started or maintained 2 hours after surgery

Exclusion criteria

• Pregnancy
• No severity criteria within the 8 hours following surgery
• Neutropenia due to chemotherapy or malignancy
• Abdominal sepsis without peritonitis
• Mesenteric ischemia without perforation
• Peritonitis due to appendicitis
• Perforation linked to trauma
• Cirrhosis child C
• Impossibility to use heparin
• Prolonged cardiac arrest within 72h before surgery
• Terminal disease diagnosed during surgery
• Moribund subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 2 patient groups

Standard therapy

Other group

Description:

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

Treatment:

Device: standard therapy

Hemoperfusion

Experimental group

Description:

standard therapy + 2 sessions of hemoperfusion within the first 24 hours

Treatment:

Device: hemoperfusion

Device: standard therapy