Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock

Phase 3

Completed

• Conditions: Septic Shock; Peritonitis
• Interventions: Device: standard therapy; Device: hemoperfusion

• Registration Number: NCT01222663
• Lead Sponsor: Meditor SAS

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2013-04
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy	standard therapy	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	hemoperfusion	standard therapy + 2 sessions of hemoperfusion within the first 24 hours
Hemoperfusion	standard therapy	standard therapy + 2 sessions of hemoperfusion within the first 24 hours

Primary Outcome Measures

Name	Time	Method
Mortality	28 days

Secondary Outcome Measures

Name	Time	Method
mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days	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
organ failure assessed by SOFA score	day 3
delay to withdraw catecholamine after initial shock	day 1-day 28

Trial Locations

Locations (18)

Roanne Hospital; 🇫🇷 Roanne, France

Dieppe Hospital; 🇫🇷 Dieppe, France

Vendée Hospital; 🇫🇷 La Roche sur Yon, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Dr Schaffner Hospital; 🇫🇷 Lens, France

Lille University Hospital; 🇫🇷 Lille, France

La Source Hospital; 🇫🇷 Orleans, France

Limoges University Hospital; 🇫🇷 Limoges, France

Lariboisière University Hospital; 🇫🇷 Paris, France

Saint Jean Hospital; 🇫🇷 Perpignan, France

Bordeaux University Hospital; 🇫🇷 Pessac, France

Saint Louis Hospital; 🇫🇷 Paris, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Pontchaillou University Hospital; 🇫🇷 Rennes, France

Saint-Malo Hospital; 🇫🇷 Saint-Malo, France

Rouen University Hospital; 🇫🇷 Rouen, France

Tours University Hospital; 🇫🇷 Tours, France

Strasbourg University Hospital; 🇫🇷 Strasbourg, France