Abstract | BACKGROUND: METHODS: EUPHRATES is a pivotal regulatory trial that is multi-centered, placebo-controlled and blinded. The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll 360 patients. Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than 2 and less than 30 hours are eligible for measurement of the EAA. Those with EAA ≥0.60 are eligible to be randomized to treatment with two sessions of PMX hemoperfusion 24 hours apart. The primary endpoint for the trial is 28-day all-cause mortality. DISCUSSION: Unique features of the trial include absence of systemic inflammatory response (SIRS) criteria as a requirement for inclusion, use of the EAA to confirm endotoxemia as a requisite for treatment, and use of a detailed "façade" hemoperfusion event as a blinding mechanism. The outcomes of the second interim analysis included a resizing of the trial to 650 patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score ( MODS) ≤ 9. Results are anticipated in 2016. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01046669. Registered: January 8, 2010.
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Authors | David J Klein, Debra Foster, Christa A Schorr, Kazem Kazempour, Paul M Walker, R Phillip Dellinger |
Journal | Trials
(Trials)
Vol. 15
Pg. 218
(Jun 11 2014)
ISSN: 1745-6215 [Electronic] England |
PMID | 24916483
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Polymyxin B
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Topics |
- Adult
- Anti-Bacterial Agents
(administration & dosage, adverse effects)
- Double-Blind Method
- Endotoxemia
(drug therapy, mortality)
- Hemoperfusion
(adverse effects, methods)
- Humans
- Polymyxin B
(administration & dosage, adverse effects)
- Research Design
- Shock, Septic
(drug therapy, mortality)
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