Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jul 19, 2020

Keywords

ClinConnect Summary

The ESCALATE trial is studying a new way to treat patients with Acute Heart Failure (AHF) in the emergency department. This trial compares two approaches: one group will receive standard care, while the other group will follow a specific treatment plan based on the amount of sodium found in their urine. The goal is to see if using this urine test can help doctors provide better, more effective treatment for patients with AHF.

To participate in this study, you need to be at least 18 years old and have been diagnosed with Acute Heart Failure after an evaluation in the emergency department. You should also show signs of fluid overload, such as swelling in your legs or difficulty breathing. If you join the trial, you can expect to be randomly assigned to one of the two treatment groups and receive close monitoring during your hospital stay. It’s important to note that certain conditions, like severe kidney disease or the need for immediate medical procedures, might prevent you from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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