Heart Failure Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

474

Study ID:

NCT04481919

Recruitment Status:

Recruiting

Sponsor:

Vanderbilt University Medical Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

VA Tennessee Valley Health Service
Nashville Tennessee, 37232, United States More Info
Sean P. Collins, MD
Contact
615-936-0253
[email protected]
Karen F. Miller, RN
Contact
615-936-4790
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Sean P Collins, MD
Contact
615-936-0253
[email protected]
Karen F. Miller, RN
Contact
615-936-4790

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

474

Study ID:

NCT04481919

Recruitment Status:

Recruiting

Sponsor:


Vanderbilt University Medical Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.