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

Primary Purpose

Gram-Negative Bacterial Infections, Sepsis, Septic Shock

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Polymyxin B immobilized fiber column
Conventional medical therapy in the ICU
Sponsored by
St. Bortolo Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Negative Bacterial Infections focused on measuring abdominal sepsis, abdominal surgery, septic shock, polymyxin B, hemoperfusion, Endotoxins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Bortolo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Blood pressure and use of vasopressors

Secondary Outcome Measures

PaO2/ FiO2 ratio
Change in SOFA score
ICU survival

Full Information

First Posted
February 26, 2008
Last Updated
December 1, 2008
Sponsor
St. Bortolo Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00629382
Brief Title
Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis
Acronym
EUPHAS
Official Title
Dispositivo Adsorbente Con Polymyxina B Immobilizzata Nello Shock Settico - Studio Clinico Randomizzato e Prospettico, Multicentrico
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Bortolo Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Negative Bacterial Infections, Sepsis, Septic Shock
Keywords
abdominal sepsis, abdominal surgery, septic shock, polymyxin B, hemoperfusion, Endotoxins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Polymyxin B immobilized fiber column
Other Intervention Name(s)
Toraymyxin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional medical therapy in the ICU
Intervention Description
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 Outcome Measure Information:
Title
Blood pressure and use of vasopressors
Time Frame
48-72 hrs
Secondary Outcome Measure Information:
Title
PaO2/ FiO2 ratio
Time Frame
48-72 hrs
Title
Change in SOFA score
Time Frame
48-72 hrs
Title
ICU survival
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St Bortolo Hospital
City
Vicenza
ZIP/Postal Code
36100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17448226
Citation
Cruz DN, Perazella MA, Bellomo R, de Cal M, Polanco N, Corradi V, Lentini P, Nalesso F, Ueno T, Ranieri VM, Ronco C. Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care. 2007;11(2):R47. doi: 10.1186/cc5780.
Results Reference
background
PubMed Identifier
19531784
Citation
Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856.
Results Reference
derived

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Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis

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