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Completed

NCT Number: NCT01222663

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clermont-Ferrand University Hospital, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard therapy

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

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.

Other names: toraymyxin, PMX-20R

Primary outcomes

  1. Mortality

    Time frame: 28 days

Secondary outcomes

  1. organ failure assessed by SOFA score

    Time frame: day 3

  2. delay to withdraw catecholamine after initial shock

    Time frame: day 1-day 28

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

    Time frame: 90 days

  4. 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

Sponsors and collaborators

Lead sponsor

Meditor SAS

Industry

Registry information

Acronym: ABDO-MIX

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2010
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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