Treatment of systemic inflammatory response syndrome by push-pull powdered sorbent pheresis: a Phase 1 clinical trial.
An FDA-approved Phase 1 feasibility study was performed in two centers to determine the safety of the BioLogic-DTPF (detoxifier/plasma filter) system for the treatment of patients with systemic inflammatory response syndrome (SIRS). This device combines hemodiabsorption (dialysis of blood against powdered sorbents with the BioLogic-DT system) with push-pull sorbent-based pheresis (the PF add-on module). Eight adult ICU patients with both SIRS and multiple organ failure participated in the study. One 6 h treatment was planned for each patient with powdered charcoal as sorbent for 4 patients and a combination of charcoal/silica in the PF sorbent bag for 4 patients. The treatments appeared to have no negative effects in 7 patients, but 1 patient died during treatment due to progressive cardiac failure. Sepsis was resolved in 5 of the 8 patients. However, there were only 2 long-term survivors of the group. The addition of the PF module should improve the chemical function of the BioLogic-DT by allowing removal of protein-bound toxins such as cytokines. The selected patients tolerated treatment by the DTPF system well, but proof of benefit of the device remains to be proven in a Phase 2 clinical trial with randomized controls.
Ash
S R
SR
HemoCleanse, Inc, West Lafayette, Indiana 47906-1349, USA. sash@hemocleanse.com
Steczko
J
J
Levy
H
H
Blake
D E
DE
Carr
D J
DJ
D000327:Adsorption; D000328:Adult; D000368:Aged; D002606:Charcoal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010956:Plasmapheresis / Q000295:instrumentation*; D012449:Safety; D012822:Silicon Dioxide; D018746:Systemic Inflammatory Response Syndrome / Q000628:therapy*
D002606:Charcoal; D012822:Silicon Dioxide