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Completed

NCT Number: NCT00629382

Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis

This clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis arising from abdominal cavity infection, accompanied by the failure of one or more organs. 120 patients (60 treatment/60 control) will be considered in this study. Those patients fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to one of two study groups. One group will be treated with PMX (PMX group) and the other will receive a "standard therapy" for sepsis (control group). All patients will receive full intensive care management, including fluid resuscitation, vasopressors, antimicrobial chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient will be followed up for 28 days after study entry.

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Key information

Conditions

Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Bortolo Hospital

Vicenza, 36100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with severe sepsis due to intra-abdominal cavity infection after emergency surgery with at least 2 SIRS criteria and 1 organ dysfunction (as defined by SCCM)

Exclusion criteria

  • Less than 18 years of age
  • Females with a positive pregnancy test
  • Treated with another investigational drug or device within the 30 days immediately preceding enrolment in this study
  • Undergone organ transplantation during the past one year
  • Documented history of sensitivity to Polymyxin-B, anticoagulant (heparin)
  • Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as "Do Not Resuscitate"
  • Diagnosed with HIV
  • Previous history of end stage chronic organ failure(s)
  • Uncontrolled hemorrhage within the last 24 h
  • Diagnosed with granulocytopenia (leukocyte count of less than 500 cells/mm3) and/or thrombocytopenia (platelet count of less than 30,000 cells/mm3)
  • More than 4 failed organs at entry
  • An APACHE II score of more than 30 at entry to the study

Treatment and study plan

Polymyxin B immobilized fiber column

Device

Hemoperfusion with PMX will be performed in ICU. The 1st PMX treatment (day 0) will be carried out for 2 hours and ideally within 24 hours but not later than 48 hours after diagnosis of severe sepsis. The second PMX treatment has to be performed 24 to 48 hours after the end of the first PMX treatment, ideally after 24 hours. Hemoperfusion therapy will be performed in addition to conventional medical therapy in the ICU.

Other names: Toraymyxin

Conventional medical therapy in the ICU

Other

Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.

Primary outcomes

  1. Blood pressure and use of vasopressors

    Time frame: 48-72 hrs

Secondary outcomes

  1. PaO2/ FiO2 ratio

    Time frame: 48-72 hrs

  2. Change in SOFA score

    Time frame: 48-72 hrs

  3. ICU survival

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

St. Bortolo Hospital

Other

Registry information

Official study title

Dispositivo Adsorbente Con Polymyxina B Immobilizzata Nello Shock Settico - Studio Clinico Randomizzato e Prospettico, Multicentrico

Acronym: EUPHAS

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2008
Registry last updated
Dec 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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