Gram-Negative Bacterial Infections, Sepsis, Septic Shock
Conditions
Keywords
abdominal sepsis, abdominal surgery, septic shock, polymyxin B, hemoperfusion, Endotoxins
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.
Interventions
DEVICEPolymyxin 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.
OTHERConventional 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.
Sponsors
St. Bortolo Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure and use of vasopressors | 48-72 hrs |
Secondary
| Measure | Time frame |
|---|---|
| PaO2/ FiO2 ratio | 48-72 hrs |
| Change in SOFA score | 48-72 hrs |
| ICU survival | 28 days |
Countries
Italy
Outcome results
None listed