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Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis (EUPHAS)

This study has been completed.
Sponsor:
Information provided by:
St. Bortolo Hospital
ClinicalTrials.gov Identifier:
NCT00629382
First received: February 26, 2008
Last updated: December 1, 2008
Last verified: April 2008

February 26, 2008
December 1, 2008
December 2004
April 2008   (final data collection date for primary outcome measure)
Blood pressure and use of vasopressors [ Time Frame: 48-72 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00629382 on ClinicalTrials.gov Archive Site
  • PaO2/ FiO2 ratio [ Time Frame: 48-72 hrs ] [ Designated as safety issue: No ]
  • Change in SOFA score [ Time Frame: 48-72 hrs ] [ Designated as safety issue: No ]
  • ICU survival [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis
Dispositivo Adsorbente Con Polymyxina B Immobilizzata Nello Shock Settico - Studio Clinico Randomizzato e Prospettico, Multicentrico

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gram-Negative Bacterial Infections
  • Sepsis
  • Septic Shock
  • Device: Polymyxin B immobilized fiber column
    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 Name: Toraymyxin
  • Other: Conventional medical therapy in the ICU
    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.
  • Experimental: 1
    Interventions:
    • Device: Polymyxin B immobilized fiber column
    • Other: Conventional medical therapy in the ICU
  • 2
    Intervention: Other: Conventional medical therapy in the ICU

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00629382
TM05
No
Claudio Ronco, MD, International Renal Research Institute Vicenza (IRRIV),
St. Bortolo Hospital
Not Provided
Not Provided
St. Bortolo Hospital
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP