SafetyandEfficacyasaResuscitativeTherapyintheICU.pptVIP

Albumin Safety and Efficacy as a Resuscitative Therapy in the ICU:Are all ICU patients the same? Gary R. Haynes, M.D., Ph.D. Professor, Department of Anesthesiology Medical University of South Carolina “SAFE” Study One-Liners on Comparative Clinical Effectiveness of Albumin and Saline 2004 Meta-analysis of Morbidity in 71 Trials in Acutely Ill Patients Volume Resuscitation in Non-Hemorrhagic Shock (primarily septic shock) Albumin vs. Crystalloid: Oxygen Delivery in Critically Ill Shock Patients Albumin Supplementation in Cirrhosis and Bacterial Peritonitis Calls for Confirmation of Trend inMortality Reduction with Albumin in Sepsis Potential Cost-Effectiveness Profile for Albumin vs. Xigris? in Severe Sepsis1 Albumin Safety and Efficacy:Recommend that FDA disseminate these points to physicians The 1998 Cochrane meta-analysis had multiple design flaws A critical flaw was inclusion of several trials whose protocols specified excessive albumin dosing, well outside the standard of practice The 2004 “SAFE” study established that albumin is not associated with an increased risk of mortality in a heterogeneous ICU population The “SAFE” study findings do not demonstrate that albumin and saline are therapeutically equivalent in individual ICU patients requiring resuscitative therapy The choice of resuscitative therapy should be individualized based on patient diagnosis, clinical presentation, relevant laboratory findings and a careful consideration of available evidence in the medical literature Albumin Safety and Efficacy:Recommend that FDA disseminate these points to physicians The “SAFE” trial documented a strong trend which suggests that albumin administration may increase survival in ICU patients with severe sepsis; definitive proof of clinical benefit awaits completion of an adequately powered trial A trend toward increased mortality was identified with albumin administration in brain-injured (but not other) trauma patients; while definitive proof awaits complet