Design and rationale of the B-lines lung ultrasound guided emergency department management of acute heart failure (BLUSHED-AHF) pilot trial.
Heart failure
Treatment
Ultrasound
emergency department
Journal
Heart & lung : the journal of critical care
ISSN: 1527-3288
Titre abrégé: Heart Lung
Pays: United States
ID NLM: 0330057
Informations de publication
Date de publication:
Historique:
received:
20
06
2018
revised:
20
10
2018
accepted:
22
10
2018
pubmed:
19
11
2018
medline:
10
3
2020
entrez:
19
11
2018
Statut:
ppublish
Résumé
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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 30448355
pii: S0147-9563(18)30228-0
doi: 10.1016/j.hrtlng.2018.10.027
pmc: PMC6486869
mid: NIHMS1511799
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03136198']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
186-192Subventions
Organisme : AHRQ HHS
ID : R01 HS025411
Pays : United States
Organisme : NHLBI NIH HHS
ID : R34 HL136986
Pays : United States
Informations de copyright
Copyright © 2018 Elsevier Inc. All rights reserved.
Références
JAMA. 2005 Oct 19;294(15):1944-56
pubmed: 16234501
Eur J Echocardiogr. 2007 Dec;8(6):474-9
pubmed: 17116422
Circulation. 2013 Oct 15;128(16):1810-52
pubmed: 23741057
Circulation. 2016 Jan 26;133(4):e38-360
pubmed: 26673558
Circulation. 2013 Oct 15;128(16):e240-327
pubmed: 23741058
Cardiovasc Ultrasound. 2015 Sep 04;13:40
pubmed: 26337295
Circulation. 2004 Oct 12;110(15):2168-74
pubmed: 15451800
Chest. 2009 Jun;135(6):1433-1439
pubmed: 19188552
Eur Heart J. 2013 Mar;34(11):835-43
pubmed: 23293303
Stat Med. 2011 Jan 15;30(1):11-21
pubmed: 21204120
JACC Heart Fail. 2013 Jun;1(3):245-51
pubmed: 24621877
Intensive Care Med. 2016 Jan;42(1):63-71
pubmed: 26474994
J Am Coll Cardiol. 2015 Jul 28;66(4):403-69
pubmed: 25553722
Eur J Heart Fail. 2008 Jan;10(1):70-7
pubmed: 18077210
J Am Soc Echocardiogr. 2006 Mar;19(3):356-63
pubmed: 16500505
JAMA. 2011 Feb 16;305(7):675-81
pubmed: 21325183
Eur J Heart Fail. 2010 May;12(5):423-33
pubmed: 20354029
Intensive Care Med. 2012 Apr;38(4):577-91
pubmed: 22392031
Int J Cardiol. 2016 Sep 1;218:104-108
pubmed: 27232920
Stat Med. 2008 Jan 30;27(2):157-72; discussion 207-12
pubmed: 17569110
Eur J Emerg Med. 2013 Oct;20(5):356-60
pubmed: 23263648
J Am Coll Cardiol. 2013 Aug 6;62(6):516-24
pubmed: 23747773
Circulation. 2010 Jul 20;122(3):265-72
pubmed: 20606118
Am Heart J. 2014 Jul;168(1):30-6
pubmed: 24952857
J Card Fail. 2015 Nov;21(11):930-4
pubmed: 26216495
Eur J Heart Fail. 2017 Sep;19(9):1154-1163
pubmed: 28557302
Am J Emerg Med. 2009 Jan;27(1):71-75
pubmed: 19041537
Am J Cardiol. 2004 May 15;93(10):1265-70
pubmed: 15135701
Am J Med. 2006 Dec;119(12 Suppl 1):S3-S10
pubmed: 17113398
Am Heart J. 2005 Feb;149(2):209-16
pubmed: 15846257
Eur J Heart Fail. 2015 Nov;17(11):1172-81
pubmed: 26417699
Acad Emerg Med. 2016 Mar;23(3):223-42
pubmed: 26910112
Circ Heart Fail. 2013 May;6(3):606-19
pubmed: 23616602
Am J Emerg Med. 2008 Jun;26(5):585-91
pubmed: 18534289
Am Heart J. 2000 Dec;140(6):840-7
pubmed: 11099986
Eur Heart J Acute Cardiovasc Care. 2015 Aug;4(4):326-32
pubmed: 25225187
Eur Heart J Acute Cardiovasc Care. 2018 Jun;7(4):311-320
pubmed: 28485200
N Engl J Med. 2009 Apr 2;360(14):1418-28
pubmed: 19339721
Chest. 2005 May;127(5):1690-5
pubmed: 15888847