Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    484
  • sponsor
    Vanderbilt University Medical Center
Updated on 4 June 2022
edema
heart failure
acute heart failure
diuretic therapy

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.

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: 1) result in significant improvement in global clinical status at 5 days relative to structured usual care, and 2) result in significant improvement in congestion at 5 days and in global rank at 30 days relative to structured usual care. Early protocolized treatment of patients with AHF will more rapidly improve dyspnea, avoid development of in-hospital WHF, result in greater decongestion at hospital discharge, and therefore prevent HF-related readmissions and CV death.

Details
Condition Heart Failure, Acute Heart Failure
Treatment Protocolized Diuretic Therapy
Clinical Study IdentifierNCT04481919
SponsorVanderbilt University Medical Center
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
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
Lack of informed consent
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