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

Information source: Meditor SAS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peritonitis; Septic Shock

Intervention: standard therapy (Device); hemoperfusion (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Meditor SAS

Official(s) and/or principal investigator(s):
Didier Payen, MD, Principal Investigator, Affiliation: Lariboisière University Hospital
René Robert, MD, Principal Investigator, Affiliation: Poitiers University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mortality

Secondary outcome:

organ failure assessed by SOFA score

delay to withdraw catecholamine after initial shock

mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days

number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Clermont-Ferrand University Hospital, Clermont-Ferrand 63058, France

Dieppe Hospital, 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, Orleans 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, Saint-Malo 35403, France

Strasbourg University Hospital, Strasbourg 67091, France

Tours University Hospital, Tours 37044, France

Additional Information

Starting date: October 2010
Last updated: December 17, 2013

Page last updated: August 23, 2015

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