Treatment of systemic inflammatory response syndrome by push-pull powdered sorbent pheresis: A phase 1 clinical trial

被引:18
作者
Ash, SR
Steczko, J
Levy, H
Blake, DE
Carr, DJ
机构
[1] HemoCleanse Inc, W Lafayette, IN 47906 USA
[2] Purdue Univ, W Lafayette, IN 47907 USA
[3] Arnett Clin, Lafayette, IN USA
[4] Univ New Mexico, Dept Med, Albuquerque, NM 87131 USA
来源
THERAPEUTIC APHERESIS | 2001年 / 5卷 / 06期
关键词
cytokines; endotoxin; extracorporeal; hemodiabsorption; plasma filter; push-pull pheresis; sepsis; silica; systemic inflammatory response syndrome; sorbent;
D O I
10.1046/j.1526-0968.2001.00298.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
An FDA-approved Phase 1 feasibility study was performed in two centers to determine the safety of the BioLogic-DTPF (detoxifies/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.
引用
收藏
页码:497 / 505
页数:9
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