Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)
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.
Conditions:
🦠 Heart Failure 🦠 Acute Heart Failure
πŸ—“οΈ Study Start (Actual) 1 May 2022
πŸ—“οΈ Primary Completion (Estimated) 30 September 2026
βœ… Study Completion (Estimated) 31 December 2026
πŸ‘₯ Enrollment (Estimated) 474
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE2
Locations:
πŸ“ Nashville, Tennessee, United States
πŸ“ Nashville, Tennessee, United States

πŸ“‹ Eligibility Criteria

Description

    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 \> 100.5ΒΊF
    • * 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
Ages Eligible for Study: 19 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 July 2020
  • First Submitted that Met QC Criteria 19 July 2020
  • First Posted 22 July 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 September 2023
  • Last Update Posted 15 September 2023
  • Last Verified September 2023