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

St. Bortolo Hospital

Status and phase

Completed

Phase 4

Conditions

Gram-Negative Bacterial Infections

Septic Shock

Sepsis

Treatments

Other: Conventional medical therapy in the ICU

Device: Polymyxin B immobilized fiber column

Study type

Interventional

Funder types

Other

Identifiers

NCT00629382

TM05

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No 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