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

Last updated: December 17, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Not Recruiting

Phase

2

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

Protocolized diuretic therapy

Clinical Study ID

NCT04481919
190690
  • Ages > 19
  • All Genders

Study 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 standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

Eligibility Criteria

Inclusion

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 venousdistension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3gallop

  • > 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

Exclusion Criteria:

  • End Stage Renal Disease (ESRD) requiring dialysis

  • Need for immediate intubation

  • Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND newST-Segment elevation/depression

  • Temperature > 100.5ºF

  • End Stage Heart Failure: transplant list or ventricular assist device

  • Concurrent use of ototoxic medications including intravenous aminoglycosides andcisplatin

  • Systolic Blood Pressure < 90 mmHg at time of consent

  • LV outflow obstruction, severe uncorrected stenotic valvular disease or severerestrictive cardiomyopathy

  • Greater than 2 doses of IV diuretic administered at the time of screening from thetime of the hospital presentation leading to this admission (outside hospital timeis included)

  • Severe, uncorrected serum electrolyte abnormalities at the time of consent (serumpotassium <3.0 mEq/L, magnesium <1.0 mEq/L or sodium <125 or >150 mEq/l)

  • Lack of informed consent

Study Design

Total Participants: 474
Treatment Group(s): 1
Primary Treatment: Protocolized diuretic therapy
Phase: 2
Study Start date:
May 01, 2022
Estimated Completion Date:
December 31, 2026

Study 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 investigators believe this would maximize diuretic efficiency, facilitate quicker resolution of congestion, avoid WHF and prolonged LOS, and reduce AHF readmissions. Propr data suggests low urine sodium predicts length of stay and outcomes after initial diuretic dosing in the outpatient and inpatient setting. Further, use of our pathway using spot urine sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with AHF has shown compelling improvements in congestion and weight loss. However, a randomized trial is necessary to determine if initiating this protocol ,started in the ED, will improve AHF outcomes relative to structured usual care. Specifically, the investigators hypothesize use of spot urine sodium guided diuretic therapy will result in significant improvement in days of benefit over the 14 days after randomization. Days of benefit combines patient symptoms captured by global clinical status with clinical state quantifying the need for hospitalization and IV diuresis.

Connect with a study center

  • VA Tennessee Valley Health Service

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • VA Tennessee Valley Health Service

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

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