A Phase 3 interventional study of Polymyxin -B fiber hemoperfusion system in Gram-Negative Bacterial Infections and Sepsis, sponsored by University of Turin, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-08.
Sponsored by University of Turin, Italy · Phase 3, Interventional, and Prevention
Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.
Acute renal failure (ARF) is a frequent complication in sepsis, in nearly to 50% of the cases, and the mortality rate is higher, compare to patients with ARF alone (70% vs 45%). Clinical and experimental studies demonstrated the key role of apoptosis, or programmed cell death, in the induction of tubular and glomerular injury in the course of sepsis. Indeed, it has been shown that inflammatory cytokines and lipopolysaccharide (LPS) cause renal tubular cell apoptosis via Fas- and caspase-mediated pathways. In addition, LPS is able to alter the normal expression pattern of sodium, urea and glucose renal transporters and to modulate tubular polarity by changing the expression of tight junction proteins with consequent back-leakage of tubular fluid in the interstitial spaces and enhancement of the inflammatory process. Therefore a novel extracorporeal therapy to remove circulating LPS, using the Polymyxin-B fiber (PMX-B) cartridge was developed. The PMX-B cartridge is an extracorporeal hemoperfusion device and consists of a polystyrene-based, fibrous adsorbent on which the polymyxin B antibiotic is covalently immobilized as a ligand to adsorb endotoxin.
Aim of this study is to verify whether the removal of LPS, using the PMX-B hemoperfusion system, protects from acute renal failure, reduces the need for Renal Replacement Therapy (RRT) and consequently improves the outcome in severe sepsis from gram negative infection.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 16 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
an extracorporeal LPS removal
Device: Polymyxin -B fiber hemoperfusion system
two hours treatment for two days
Also known as: PMX-B
Number of Participants Not Requiring Renal Replacement Therapy (RRT)
Time frame: 28 days from the admission
The Reduction of the Number of Apoptotic Cells, Stimulated With Plasma Derives From Septic Patients With Gram Negative Infection, Treated With PMX-B Hemoperfusion, on Immortalized Tubular and Glomerular Cell Cultures.
Time frame: 72 hours after randomization
| Milestone | Conventional Treatment (CONV) | Polymyxin-B Hemoperfusion Treatment (PMX-B) |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| participants | Conventional Treatment (CONV) | Polymyxin-B Hemoperfusion Treatment (PMX-B) |
|---|---|---|
| Number of Participants Not Requiring Renal Replacement Therapy (RRT) | 3 | 1 |
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Treatment (CONV) | — | 0/8 (0%) | 0/8 (0%) |
| Polymyxin-B Hemoperfusion Treatment (PMX-B) | — | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Conventional Treatment (CONV) | Polymyxin-B Hemoperfusion Treatment (PMX-B) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 4 | 10 |
| >=65 years | 2 | 4 | 6 |
| Age Continuous(years) | Conventional Treatment (CONV) | Polymyxin-B Hemoperfusion Treatment (PMX-B) | Total |
|---|---|---|---|
| Mean | 59 ± 13 | 61 ± 10 | 60 ± 11 |
| Sex: Female, Male(Participants) | Conventional Treatment (CONV) | Polymyxin-B Hemoperfusion Treatment (PMX-B) | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 6 | 6 | 12 |
| Region of Enrollment(participants) | Conventional Treatment (CONV) | Polymyxin-B Hemoperfusion Treatment (PMX-B) | Total |
|---|---|---|---|
| Italy | 8 | 8 | 16 |
This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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University of Turin, Italy