Frances M Russell1, Robert R Ehrman2, Robinson Ferre3, Luna Gargani4, Vicki Noble5, Jordan Rupp3, Sean P Collins3, Benton Hunter1, Kathleen A Lane6, Phillip Levy7, Xiaochun Li6, Christopher O'Connor8, Peter S Pang9. 1. Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. 2. Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, USA. 3. Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. 4. Institute of Clinical Physiology, National Research Council, Pisa, Italy. 5. Department of Emergency Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. 6. Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA. 7. Department of Emergency Medicine and Integrative Biosciences Center, Wayne State University, Detroit, MI, USA. 8. Division of Cardiology, INOVA Heart and Vascular Institute, Falls Church, VA, USA. 9. Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis EMS, Indianapolis, IN, USA. Electronic address: ppang@iu.edu.
Abstract
BACKGROUND: Medical treatment for acute heart failure (AHF) has not changed substantially over the last four decades. Emergency department (ED)-based evidence for treatment is limited. Outcomes remain poor, with a 25% mortality or re-admission rate within 30days post discharge. Targeting pulmonary congestion, which can be objectively assessed using lung ultrasound (LUS), may be associated with improved outcomes. METHODS: BLUSHED-AHF is a multicenter, randomized, pilot trial designed to test whether a strategy of care that utilizes a LUS-driven treatment protocol outperforms usual care for reducing pulmonary congestion in the ED. We will randomize 130 ED patients with AHF across five sites to, a) astructured treatment strategy guided by LUS vs. b) a structured treatment strategy guided by usual care. LUS-guided care will continue until there are ≤15 B-lines on LUS or 6h post enrollment. The primary outcome is the proportion of patients with B-lines ≤ 15 at the conclusion of 6 h of management. Patients will continue to undergo serial LUS exams during hospitalization, to better understand the time course of pulmonary congestion. Follow up will occur through 90days, exploring days-alive-and-out-of-hospital between the two arms. The study is registered on ClinicalTrials.gov (NCT03136198). CONCLUSION: If successful, this pilot study will inform future, larger trial design on LUS driven therapy aimed at guiding treatment and improving outcomes in patients with AHF.
RCT Entities:
BACKGROUND: Medical treatment for acute heart failure (AHF) has not changed substantially over the last four decades. Emergency department (ED)-based evidence for treatment is limited. Outcomes remain poor, with a 25% mortality or re-admission rate within 30days post discharge. Targeting pulmonary congestion, which can be objectively assessed using lung ultrasound (LUS), may be associated with improved outcomes. METHODS: BLUSHED-AHF is a multicenter, randomized, pilot trial designed to test whether a strategy of care that utilizes a LUS-driven treatment protocol outperforms usual care for reducing pulmonary congestion in the ED. We will randomize 130 ED patients with AHF across five sites to, a) a structured treatment strategy guided by LUS vs. b) a structured treatment strategy guided by usual care. LUS-guided care will continue until there are ≤15 B-lines on LUS or 6h post enrollment. The primary outcome is the proportion of patients with B-lines ≤ 15 at the conclusion of 6 h of management. Patients will continue to undergo serial LUS exams during hospitalization, to better understand the time course of pulmonary congestion. Follow up will occur through 90days, exploring days-alive-and-out-of-hospital between the two arms. The study is registered on ClinicalTrials.gov (NCT03136198). CONCLUSION: If successful, this pilot study will inform future, larger trial design on LUS driven therapy aimed at guiding treatment and improving outcomes in patients with AHF.
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