Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock (ABDO-MIX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meditor SAS
ClinicalTrials.gov Identifier:
NCT01222663
First received: October 8, 2010
Last updated: December 17, 2013
Last verified: December 2013

October 8, 2010
December 17, 2013
October 2010
April 2013   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01222663 on ClinicalTrials.gov Archive Site
  • organ failure assessed by SOFA score [ Time Frame: day 3 ] [ Designated as safety issue: Yes ]
  • delay to withdraw catecholamine after initial shock [ Time Frame: day 1-day 28 ] [ Designated as safety issue: No ]
  • mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion) [ Time Frame: day1-day4 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock
Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peritonitis
  • Septic Shock
  • 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
  • Device: 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.
    Other Names:
    • toraymyxin
    • PMX-20R
  • 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: Device: standard therapy
  • Experimental: Hemoperfusion
    standard therapy + 2 sessions of hemoperfusion within the first 24 hours
    Interventions:
    • Device: standard therapy
    • Device: hemoperfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
December 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01222663
2010-67-PMX
Yes
Meditor SAS
Meditor SAS
Not Provided
Principal Investigator: Didier Payen, MD Lariboisière University Hospital
Principal Investigator: René Robert, MD Poitiers University Hospital
Meditor SAS
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP