Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis

Sepsis Clinical Trial

— EUPHAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629382
• Other study ID #: TM05
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2008
• Last updated: December 1, 2008
• Start date: December 2004
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: St. Bortolo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Gram-Negative Bacterial Infections
• Sepsis
• Septic Shock
• Shock, Septic

Intervention

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:
• 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.

Locations

Country	Name	City	State
Italy	St Bortolo Hospital	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
St. Bortolo Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure and use of vasopressors		48-72 hrs	No
Secondary	PaO2/ FiO2 ratio		48-72 hrs	No
Secondary	Change in SOFA score		48-72 hrs	No
Secondary	ICU survival		28 days	No