Clinical trial NCT01222663: Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock
Official title: Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peritonitis
Septic Shock
Keywords: peritonitis
septic shock
hemoperfusion
Polymyxin B
endotoxin
Lead sponsor: Meditor SAS
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: organ failure assessed by SOFA score
timeFrame: day 3
measure: delay to withdraw catecholamine after initial shock
timeFrame: day 1-day 28
measure: mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days
timeFrame: 90 days
measure: number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion)
timeFrame: day1-day4
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Dieppe
country: France
facility: Dieppe Hospital
city: La Roche sur Yon
country: France
facility: Vendée Hospital
city: Lens
country: France
facility: Dr Schaffner Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Orleans
country: France
facility: La Source Hospital
city: Paris
country: France
facility: Lariboisière University Hospital
city: Paris
country: France
facility: Saint Louis Hospital
city: Perpignan
country: France
facility: Saint Jean Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Pontchaillou University Hospital
city: Roanne
country: France
facility: Roanne Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Saint-Malo
country: France
facility: Saint-Malo Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Lariboisière University Hospital
name: Didier Payen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poitiers University Hospital
name: René Robert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.