| Treatment of systemic inflammatory response syndrome by push-pull powdered sorbent pheresis: a Phase 1 clinical trial. | |
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MedLine Citation:
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PMID: 11800089 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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S R Ash; J Steczko; H Levy; D E Blake; D J Carr |
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Publication Detail:
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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:
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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:
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Created Date: 2002-01-21 Completed Date: 2002-05-03 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9706703 Medline TA: Ther Apher Country: United States |
Other Details:
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Languages: eng Pagination: 497-505 Citation Subset: IM |
Affiliation:
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HemoCleanse, Inc, West Lafayette, Indiana 47906-1349, USA. sash@hemocleanse.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adsorption Adult Aged Charcoal Female Humans Male Middle Aged Plasmapheresis / instrumentation* Safety Silicon Dioxide Systemic Inflammatory Response Syndrome / therapy* |
| Chemical | |
Reg. No./Substance:
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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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