Status:
ACTIVE_NOT_RECRUITING
Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Heart Failure
Acute Heart Failure
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial stan...
Detailed Description
A standardized protocol driven treatment pathway for hospitalized patients started in the first few hours of ED evaluation and utilizing objective measures of diuretic response is needed. The investig...
Eligibility Criteria
Inclusion
- Age \> 18
- Emergency Department diagnosis of Acute Heart Failure (AHF)
- Any one of the following:
- i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop
- \> 10 pounds of volume overload physician estimate or historical dry weight
- IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay
Exclusion
- End Stage Renal Disease (ESRD) requiring dialysis
- Need for immediate intubation
- Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression
- Temperature \> 100.5ºF
- End Stage Heart Failure: transplant list or ventricular assist device
- Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin
- Systolic Blood Pressure \< 90 mmHg at time of consent
- LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy
- Greater than 2 doses of IV diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included)
- Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium \<3.0 mEq/L, magnesium \<1.0 mEq/L or sodium \<125 or \>150 mEq/l)
- Lack of informed consent
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT04481919
Start Date
May 1 2022
End Date
December 31 2026
Last Update
December 19 2025
Active Locations (2)
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1
VA Tennessee Valley Health Service
Nashville, Tennessee, United States, 37232
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232