Document Detail


Treatment of systemic inflammatory response syndrome by push-pull powdered sorbent pheresis: a Phase 1 clinical trial.
MedLine Citation:
PMID:  11800089     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
S R Ash; J Steczko; H Levy; D E Blake; D J Carr
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Therapeutic apheresis : official journal of the International Society for Apheresis and the Japanese Society for Apheresis     Volume:  5     ISSN:  1091-6660     ISO Abbreviation:  Ther Apher     Publication Date:  2001 Dec 
Date Detail:
Created Date:  2002-01-21     Completed Date:  2002-05-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9706703     Medline TA:  Ther Apher     Country:  United States    
Other Details:
Languages:  eng     Pagination:  497-505     Citation Subset:  IM    
Affiliation:
HemoCleanse, Inc, West Lafayette, Indiana 47906-1349, USA. sash@hemocleanse.com
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MeSH Terms
Descriptor/Qualifier:
Adsorption
Adult
Aged
Charcoal
Female
Humans
Male
Middle Aged
Plasmapheresis / instrumentation*
Safety
Silicon Dioxide
Systemic Inflammatory Response Syndrome / therapy*
Chemical
Reg. No./Substance:
16291-96-6/Charcoal; 7631-86-9/Silicon Dioxide

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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