Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock
ABDO-MIX
1 other identifier
interventional
243
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 18, 2013
December 1, 2013
2.5 years
October 8, 2010
December 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
28 days
Secondary Outcomes (4)
organ failure assessed by SOFA score
day 3
delay to withdraw catecholamine after initial shock
day 1-day 28
mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days
90 days
number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion)
day1-day4
Study Arms (2)
Standard therapy
OTHERStandard 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
EXPERIMENTALstandard therapy + 2 sessions of hemoperfusion within the first 24 hours
Interventions
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.
Eligibility Criteria
You may qualify if:
- Confirmed community or nosocomial acquired peritonitis due to organ perforation
- Septic shock requiring catecholamine infusion started or maintained 2 hours after surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meditor SASlead
Study Sites (18)
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63058, France
Dieppe Hospital
Dieppe, 76202, France
Vendée Hospital
La Roche-sur-Yon, 85925, France
Dr Schaffner Hospital
Lens, 62307, France
Lille University Hospital
Lille, 59037, France
Limoges University Hospital
Limoges, 87042, France
La Source Hospital
Orléans, 45067, France
Lariboisière University Hospital
Paris, 75010, France
Saint Louis Hospital
Paris, 75475, France
Saint Jean Hospital
Perpignan, 66046, France
Bordeaux University Hospital
Pessac, 33600, France
Poitiers University Hospital
Poitiers, 86021, France
Pontchaillou University Hospital
Rennes, 35033, France
Roanne Hospital
Roanne, 42300, France
Rouen University Hospital
Rouen, 76031, France
Saint-Malo Hospital
St-Malo, 35403, France
Strasbourg University Hospital
Strasbourg, 67091, France
Tours University Hospital
Tours, 37044, France
Related Publications (1)
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.
PMID: 25862039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Payen, MD
Lariboisière University Hospital
- PRINCIPAL INVESTIGATOR
René Robert, MD
Poitiers University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 18, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2013
Study Completion
December 1, 2013
Last Updated
December 18, 2013
Record last verified: 2013-12