Health Condition 1: null- Severe Sepsis and Septic Shock originating in the abdominal cavity, urinary tract or any other organ system supported by high activity levels of endotoxin (EAA value greater than or equal to 0.6)
Conditions
Interventions
Intervention1: PMX-DHP: Polymyxin B-Direct Hemoperfusion(PMX-DHP)
PMX-20R device
Sponsors
Estor SpA
LG Life Sciences India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: This project is an open, multicentered and collaborative data collection, which will study the usage of Polymyxin B Direct Hemoperfusion treatment in clinical practice. This will include patients with severe sepsis or septic shock originating in the abdominal cavity, urinary tract or otherwise supported by high activity levels of endotoxin (Endotoxin Activity Assay value greater than or equal to 0.6) measured by chemiluminescence in whole blood and accompanied by the dysfunction of one or more organs. All patients will be managed applying the standard protocols of intensive care, including the infusion of fluids, administration of vasopressor, mechanical ventilation, antimicrobial chemotherapy, the support of renal function such as continuous renal replacement therapy and hemodialysis, if necessary. Therefore, the inclusion of patients in the database will not, under any circumstances, impose any change on patient management.
Exclusion criteria
Exclusion criteria: As this is open, multicentered and collaborative data collection web based registry, there are no specific exclusion criteria with subject to database collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the treatment will be assessed with the following criteria: -20% decrease of vasopressors dependency Index at 72 hours. -Reduction of 3.5 points on delta sofa score at 72 hours. -Renal function: significant improvement of urine output and/or frequency of continuous renal replacement therapy. -Respiratory Function: significant improvement in the oxygen metabolism, blood gases and/or Mechanical Ventilation free days.Timepoint: The data base will track each patient for 29 days (from day 0 to day 28) following the Polymyxin B Direct Hemoperfusion treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in the ICU length of stay and ICU-free days 2. Patient prognosisTimepoint: The data base will track each patient for 29 days (from day 0 to day 28) | — |
Countries
India, Italy, Switzerland
Contacts
Public ContactWalter Rajkumar
LG Life Sciences India Pvt Ltd
Outcome results
None listed