Clinical trial

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

Name
1R34HL136986-01
Description
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.
Trial arms
Trial start
2017-07-10
Estimated PCD
2019-03-20
Trial end
2019-06-20
Status
Completed
Phase
Early phase I
Treatment
LUS-guided strategy-of-care
For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first. Treatment protocol: 1. IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive. 2. Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV) 3. Reassessment every 2 hours
Arms:
LUS-guided strategy-of-care
Usual Care
Patients will receive usual AHF care
Arms:
Usual care
Intravenous Loop Diuretic
IV loop diuretic
Arms:
LUS-guided strategy-of-care, Usual care
Vasodilator
IV, topical, or SL Vasodilator
Arms:
LUS-guided strategy-of-care, Usual care
Non invasive Ventilation (NIV)
Face, mouth, or nasal mask applied to provide positive pressure ventilation
Arms:
LUS-guided strategy-of-care, Usual care
Size
130
Primary endpoint
Number of Participants With B-lines ≤ 15 at the Conclusion of ED AHF Management
During the ED phase of management, usually no more than 6 hours
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'A central, independent, Core Lab will review all images.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ACTUAL'}}
Updated at
2024-06-04

1 organization

2 products

3 indications

Organization
Indiana University
Indication
Pulmonary Edema