NCT04481919Active, not recruitingPhase 2
Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)
A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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 standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 474 (estimated)
- First submitted
- 19 Jul 2020
- Start date
- 1 May 2022
- Primary completion date
- 22 Nov 2025
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Heart failure
- NCT number
- NCT04481919
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 474
- From 1 May 2022 to the primary completion date, 22 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin
Other illness
- End Stage Renal Disease (ESRD) requiring dialysis
- Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression
- End Stage Heart Failure: transplant list or ventricular assist device
- LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy
Lab values
- 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)
Other
- Need for immediate intubation
- Temperature \> 100.5ºF
- Systolic Blood Pressure \< 90 mmHg at time of consent
- 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)
- Lack of informed consent
Who the study is looking for
- Age \> 18
- Emergency Department diagnosis of Acute Heart Failure (AHF)
- Any one of the following:
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Tennessee Valley Health Service Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
Related publications
- Assessment of Ototoxicity in Patients With Heart Failure Receiving High-Dose IV Loop Diuretics.JAMA Cardiol · 2026 · PMID 42961411
This page is information, not medical advice. Discuss any trial with your doctor.