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 scoredelay 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
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