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PeritonitisPhase 3ABDO-MIXNCT01222663

Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock

A Phase 3 study testing standard therapy and hemoperfusion in people with Peritonitis and Septic Shock, run by Meditor SAS at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritonitis, Septic Shock
What is being tested?
standard therapy and hemoperfusion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
18 sitesFrance
Study dates
Oct 2010to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed community or nosocomial acquired peritonitis due to organ perforation
  • Septic shock requiring catecholamine infusion started or maintained 2 hours after surgery

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63058

  • Dieppe Hospital

    Dieppe, 76202

  • Vendée Hospital

    La Roche-sur-Yon, 85925

  • Dr Schaffner Hospital

    Lens, 62307

  • Lille University Hospital

    Lille, 59037

  • Limoges University Hospital

    Limoges, 87042

  • La Source Hospital

    Orléans, 45067

  • Lariboisière University Hospital

    Paris, 75010

  • Saint Louis Hospital

    Paris, 75475

  • Saint Jean Hospital

    Perpignan, 66046

  • Bordeaux University Hospital

    Pessac, 33600

  • Poitiers University Hospital

    Poitiers, 86021

  • Pontchaillou University Hospital

    Rennes, 35033

  • Roanne Hospital

    Roanne, 42300

  • Rouen University Hospital

    Rouen, 76031

  • Saint-Malo Hospital

    St-Malo, 35403

  • Strasbourg University Hospital

    Strasbourg, 67091

  • Tours University Hospital

    Tours, 37044

Other trials in France

About this study

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.

Read the 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.

Being tested
standard therapy, hemoperfusion
Keywords
peritonitis, septic shock, hemoperfusion, Polymyxin B, endotoxin
Medical subject headings
Peritonitis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard therapyDevice

    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

  • hemoperfusionDevice

    Also called toraymyxin, PMX-20R

    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.

Study groups in NCT01222663
Study groupRoleWhat they receive
Standard therapyOtherStandard 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
Receives: Device: standard therapy
HemoperfusionExperimentalstandard therapy + 2 sessions of hemoperfusion within the first 24 hours
Receives: Device: standard therapy; Device: hemoperfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 28 days

Secondary outcomes (4)

  1. organ failure assessed by SOFA score

    Measured: day 3

  2. delay to withdraw catecholamine after initial shock

    Measured: day 1-day 28

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

    Measured: 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)

    Measured: day1-day4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01222663
Sponsor's protocol ID
2010-67-PMX
Acronym
ABDO-MIX
Status last verified
Dec 2013
First submitted
8 Oct 2010
Last updated
18 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25862039

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing standard therapy and hemoperfusion in people with Peritonitis and Septic Shock, run by Meditor SAS at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01222663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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