B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial

• Status: Completed
• Trial end date: 2019-06-20
• Target enrollment: 0
• Participant gender: All

Summary

Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve outcomes. ED treatment is largely the same today as 40 years ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary reason why patients present to the hospital for AHF. Treating congestion is the cornerstone of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested. The investigators propose a novel approach to aggressively decongest patients in the ED setting: lung ultrasound guided, protocol driven, AHF management. LUS B-lines are a measure of extra-vascular lung water (EVLW). In the setting of AHF, LUS B-lines are a measure of congestion. This simple, easily learned technique has excellent reliability and reproducibility. The investigators hypothesize that a strategy-of-care will outperform usual care. At the present time, usual care is largely empirical. This study will improve the evidence base for ED AHF management. This proposed pilot study, if successful, will lead to an outcome trial examining whether an ED AHF strategy-of-care increases days alive and out of the hospital for patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborators: Case Western Reserve University; Inova Fairfax Hospital; Vanderbilt University; Wayne State University
• Treatments: Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Vasodilator Agents

Criteria

Inclusion Criteria:

• Age ≥ 21 years

• Presents with shortness of breath at rest or with minimal exertion

• Clinical diagnosis of AHF and presence of > 15 total bilateral B-lines distributed in at least 4 zones on initial LUS

• Hx of chronic HF and any one of the following:

• Chest radiograph consistent with AHF

• Jugular venous distension

• Pulmonary rales on auscultation

• Lower extremity edema

Exclusion Criteria:

• Chronic renal dysfunction, including end-stage renal disease (ESRD) or estimated glomerular filtration rate (eGFR) < 45ml//min/1.73m2.

• Shock of any kind. Any requirement for vasopressors or inotropes.

• Systolic blood pressure (SBP) < 100 or >175 mmHg

• Need for immediate intubation

• Acute Coronary Syndrome- Presentation consistent with myocardial ischemia AND either new ST-segment elevation/depression

• Fever >101.5 ºF or chest radiograph or clinical picture of pneumonia

• End stage HF: transplant list, ventricular assist device

• Anemia requiring transfusion

• Known interstitial lung disease

• Suspected acute lung injury or acute respiratory distress syndrome (ARDS)

• Pregnant or recently pregnant within the last 6 months