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

NCT ID: NCT01222663

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peritonitis Septic Shock

Keywords

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peritonitis septic shock hemoperfusion Polymyxin B endotoxin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

standard therapy

Intervention Type 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

Hemoperfusion

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

Group Type EXPERIMENTAL

hemoperfusion

Intervention Type 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.

standard therapy

Intervention Type 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

Interventions

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hemoperfusion

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.

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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toraymyxin PMX-20R

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meditor SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier Payen, MD

Role: PRINCIPAL_INVESTIGATOR

Lariboisière University Hospital

René Robert, MD

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, , France

Site Status

Dieppe Hospital

Dieppe, , France

Site Status

Vendée Hospital

La Roche-sur-Yon, , France

Site Status

Dr Schaffner Hospital

Lens, , France

Site Status

Lille University Hospital

Lille, , France

Site Status

Limoges University Hospital

Limoges, , France

Site Status

La Source Hospital

Orléans, , France

Site Status

Lariboisière University Hospital

Paris, , France

Site Status

Saint Louis Hospital

Paris, , France

Site Status

Saint Jean Hospital

Perpignan, , France

Site Status

Bordeaux University Hospital

Pessac, , France

Site Status

Poitiers University Hospital

Poitiers, , France

Site Status

Pontchaillou University Hospital

Rennes, , France

Site Status

Roanne Hospital

Roanne, , France

Site Status

Rouen University Hospital

Rouen, , France

Site Status

Saint-Malo Hospital

St-Malo, , France

Site Status

Strasbourg University Hospital

Strasbourg, , France

Site Status

Tours University Hospital

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25862039 (View on PubMed)

Other Identifiers

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2010-67-PMX

Identifier Type: -

Identifier Source: org_study_id