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The risk of Severe DIAR in Trauma Patients given HSD

The risk of Severe DIAR in Trauma Patients given HSD. Eileen M. Bulger, MD Associate Professor of Surgery Co-PI Resuscitation Outcomes Consortium. Hypertonic Saline Dextran. 7.5% saline/6% dextran-70, 250cc given as initial resuscitation fluid for patients with hypovolemic shock

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The risk of Severe DIAR in Trauma Patients given HSD

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  1. The risk of Severe DIAR in Trauma Patients given HSD Eileen M. Bulger, MD Associate Professor of Surgery Co-PI Resuscitation Outcomes Consortium

  2. Hypertonic Saline Dextran • 7.5% saline/6% dextran-70, 250cc given as initial resuscitation fluid for patients with hypovolemic shock • Approved in 14 European countries, Rescueflow, Biophausia Inc, Sweden • 8 previous clinical trials,meta-analysis demonstrates improved survival OR 1.47 and 2 fold increase in survival for patients with traumatic brain injury1,2

  3. Advantages of HSD Resuscitation3 • More rapid restoration of perfusion with small volume • Improved cerebral perfusion while decreasing intracranial pressure • May alter the response of the immune system after injury: • Decrease the risk of developing lung injury (ARDS) by inhibiting neutrophil and monocyte activation • Reduce nosocomial infection by enhanced T cell function

  4. Current & Proposed Trials • Current trial at University of Washington • Phase 2 trial, primary endpoint ARDS • Current enrollment 205pts, now on clinical hold • Proposed ROC trial • Phase 3 trial, n=3018 • Hypovolemic shock- 28 day survival • Traumatic Brain Injury- Neurologic outcome

  5. Resuscitation Outcomes Consortium • NIH • NHLBI • NINDS • CIHR • US DOD • Canadian DOD

  6. Limitations of Prior reports of DIAR • Elective surgery, older population (mean age 60yrs), high rate w/ epidural or spinal anaesthesia • Relies on comparison to historical controls from 1970-1979 • No randomized controlled trial data available

  7. Risk of Severe DIAR in Trauma patients • Experience with HSD • 900 pts in clinical trials, 20,100pts treated in Europe • NO REPORTS OF DIAR • 0/21000, < 5/100,000 • Estimates based on Hypertonic hetastarch experience: 4-8/100,0004.5

  8. Comparison of Risk for Severe DIAR

  9. Why Trauma patients may be protected? • High circulating levels of catecholamines • Rapid infusion of the solution may result in an excess of antigen in the blood and thus prevent the formation of immune complexes.

  10. Limitations of Promit • Side effects: 1-57/100,0009,10 • Skin reactions • Bradycardia +/- hypotension • Hypotension • HSD most effective as first fluid given • Premedication may delay medic from other critical interventions • Feasibility in prehospital or battlefield setting • Immuno-modulatory effects of Promit are unknown. May interfere with the effectiveness of HSD

  11. Summary • Trauma patients receiving HSD at much lower risk of severe DIAR than previous reports. • To date no reports of DIAR with 21,000 patients receiving HSD. • There is no statistical difference between the estimated risk of severe DIAR for trauma patients receiving HSD and the projected risk with Promit pre-treatment for dextran infusion. • We ask the committee to consider whether Promit premedication should be required in this circumstance.

  12. References • Wade C, Grady J, Kramer G. Efficacy of hypertonic saline dextran (HSD) in patients with traumatic hypotension: meta-analysis of individual patient data. Acta Anaesthesiol Scand Suppl 1997;110: 77-9 • Wade C, Grady J, Kramer G et al. Individual patient cohort analysis of the efficacy of hypertonic saline/dextran in patients with traumatic brain injury and hypotension.1997 J Trauma 42:S61-5 • Svensen C, Hypertonic Solutions: an update. ITACCS 2002, 6-12 • Schimetta W, Schochl H, Kroll W et al. Safety of hypertonic hyperoncotic solutions-a survey from Austria. Wien Klin Wochenschr 2002, 114:89-95. • Barron ME, Wilkes MM, Navickis RJ. A systematic review of the comparative safety of colloids. Arch Surg 2004, 139:552-563 • Ljungstrom KG, Renck H, Standberg K et al. Reactions to dextran in Sweden 1970-1979. Acta Chir Scand 149: 253-262, 1983. • Hedin H, Ljungstrom K. Prevention of dextran anaphylaxis: ten years experience with hapten dextran. Int Arch Allergy Immunol 1997, 113:358-359. • Ring J,Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitute. Lancet, 1977466-469. • Renck H, Ljungstrom K, Hedin H et al. Prevention of dextran-induced anaphylactic reactions by hapten inhibition. Acta Chir Scand 149:355-360, 1983. • Ljungstrom K, Willman B, Hedin H. Hapten inhibition of dextran anaphylaxis. Nine years of post-marketing surveillance of dextran 1. Ann Fr Anesth Reanim 12:219-222, 1993. • Yocum MW, Butterfield JH, Klein JS et al. Epidemiology of anaphylaxis in Olmsted County: a population-based study. J allergy Clin Immunol, 1999 104:452-457

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