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
  Purpose

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.


Condition Intervention Phase
Peritonitis
Septic Shock
Device: standard therapy
Device: hemoperfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock

Resource links provided by NLM:


Further study details as provided by Meditor SAS:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 243
Study Start Date: October 2010
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
Experimental: Hemoperfusion
standard therapy + 2 sessions of hemoperfusion within the first 24 hours
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222663

Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63058
Dieppe Hospital
Dieppe, France, 76202
Vendée Hospital
La Roche sur Yon, France, 85925
Dr Schaffner Hospital
Lens, France, 62307
Lille University Hospital
Lille, France, 59037
Limoges University Hospital
Limoges, France, 87042
La Source Hospital
Orleans, France, 45067
Lariboisière University Hospital
Paris, France, 75010
Saint Louis Hospital
Paris, France, 75475
Saint Jean Hospital
Perpignan, France, 66046
Bordeaux University Hospital
Pessac, France, 33600
Poitiers University Hospital
Poitiers, France, 86021
Pontchaillou University Hospital
Rennes, France, 35033
Roanne Hospital
Roanne, France, 42300
Rouen University Hospital
Rouen, France, 76031
Saint-Malo Hospital
Saint-Malo, France, 35403
Strasbourg University Hospital
Strasbourg, France, 67091
Tours University Hospital
Tours, France, 37044
Sponsors and Collaborators
Meditor SAS
Investigators
Principal Investigator: Didier Payen, MD Lariboisière University Hospital
Principal Investigator: René Robert, MD Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Meditor SAS
ClinicalTrials.gov Identifier: NCT01222663     History of Changes
Other Study ID Numbers: 2010-67-PMX
Study First Received: October 8, 2010
Last Updated: December 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Meditor SAS:
peritonitis
septic shock
hemoperfusion
Polymyxin B
endotoxin

Additional relevant MeSH terms:
Peritonitis
Shock
Shock, Septic
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Polymyxin B
Polymyxins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014