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

Septic Shock Clinical Trial

— ABDO-MIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222663
• Other study ID #: 2010-67-PMX
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2010
• Last updated: December 17, 2013
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Meditor SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Peritonitis
• Septic Shock
• Shock
• Shock, Septic

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Dieppe Hospital	Dieppe
France	Vendée Hospital	La Roche sur Yon
France	Dr Schaffner Hospital	Lens
France	Lille University Hospital	Lille
France	Limoges University Hospital	Limoges
France	La Source Hospital	Orleans
France	Lariboisière University Hospital	Paris
France	Saint Louis Hospital	Paris
France	Saint Jean Hospital	Perpignan
France	Bordeaux University Hospital	Pessac
France	Poitiers University Hospital	Poitiers
France	Pontchaillou University Hospital	Rennes
France	Roanne Hospital	Roanne
France	Rouen University Hospital	Rouen
France	Saint-Malo Hospital	Saint-Malo
France	Strasbourg University Hospital	Strasbourg
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Meditor SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		28 days	Yes
Secondary	organ failure assessed by SOFA score		day 3	Yes
Secondary	delay to withdraw catecholamine after initial shock		day 1-day 28	No
Secondary	mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days		90 days	No
Secondary	number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion)		day1-day4	Yes