A Phase 3 interventional study of standard therapy and hemoperfusion in Peritonitis and Septic Shock, sponsored by Meditor SAS. Completed at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Meditor SAS · Phase 3, Interventional, and Treatment
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 243 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →This is the only study on the registry with Meditor SAS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: standard therapy
standard therapy + 2 sessions of hemoperfusion within the first 24 hours
Device: standard therapy · Device: hemoperfusion
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
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.
Also known as: toraymyxin, PMX-20R
Mortality
Time frame: 28 days
organ failure assessed by SOFA score
Time frame: day 3
delay to withdraw catecholamine after initial shock
Time frame: day 1-day 28
mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days
Time frame: 90 days
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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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