Patients in Septic Shock Clinical Trial
Official title:
The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study
| NCT number | NCT01948778 |
| Other study ID # | ENDoX_CH012 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2013 |
| Est. completion date | July 2019 |
| Verified date | June 2019 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Septic shock has a high mortality risk despite the availability of various treatments.
Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger
of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming
systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with
generalized vascular endothelial damage, tissue injury and multi-organ failure.
Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin.
Different extracorporeal blood purification systems are available. The oXiris™ device
comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma
cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the
membrane allows absorbing negatively charged bacterial products such as endotoxin. From an
historical perspective, filters containing AN69-based membranes have been the most commonly
used products for CRRT in the management of critically ill patients and a substantial volume
of published data exist.
Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX)
filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of
polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the
polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity.
Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating
endotoxin by adsorption.
- Trial with medical device
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | July 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: • Patients with septic shock, defined as 30ml/kg of i.v. fluid
administered within a period of 6 hours after initiation of vasopressor therapy with a
vasopressor index =3, and at least one of the following criteria: metabolic acidosis,
neurologic dysfunction, renal dysfunction, or acute hepatic dysfunction - Male and Female patients =18 years - Endotoxin levels =0.6 IU EAA (measured at ICU admission and repeated 24 hours later in case the initial value is =0.4 and <0.6) Exclusion criteria: • Endotoxin levels <0.6 IU EAA - Pregnancy or breast feeding - Neutropenia (circulating neutrophils <500/µl) - Pre-existing immune deficiencies or immune-suppressive therapy, especially corticosteroids - Use of Vasopressin (Pitressin?) - Organ transplantation within the last 12 months - Terminally ill patients classified as "do not resuscitate" - History of sensitivity to polymyxin B or to anticoagulant (heparin) HIT or allergy to heparin - Need for extracorporeal membrane oxygenation (ECMO) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of the endotoxin activity 72 hours after treatment initiation | 72 hours |