Phase 3 N=16 Randomized Prevention

The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial

Gram-Negative Bacterial Infections · Sepsis

Bottom Line

View on ClinicalTrials.gov: NCT00490477 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2010

Primary outcome: Primary: Number of Participants Not Requiring Renal Replacement Therapy (RRT) — 3; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Polymyxin -B fiber hemoperfusion system (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Turin, Italy
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Not Requiring Renal Replacement Therapy (RRT)	3; 1	—
SECONDARY 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.	—	—

Summary

Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.

Eligibility Criteria

Inclusion Criteria

Endotoxemia associated to severe sepsis

Exclusion Criteria

Age 30
Lack of consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00490477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.