# A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients with Acute Heart Failure

> **NIH NIH R61** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 · $881,233

## Abstract

Abstract
Of the one million emergency department (ED) patients hospitalized with acute heart failure (AHF), loop
diuretics are the only IV treatment used over 80% of the time, although only with level of evidence C. Prior
studies have focused on the initial dose of IV diuretic and failed to find one strategy with maximal efficacy.
Diuretic dosing and response vary widely, leaving many patients inadequately treated. Some have a clinical
response to diuretic therapy resulting in symptom improvement and discharge from the hospital within 3-5
days. However, despite apparent symptom improvement, 50% of these patients experience no weight loss and
up to 50% leave the hospital with residual congestion. Patients with residual congestion and minimal weight
loss at hospital discharge experience a disproportionately high number of readmissions. Up to 20% of
hospitalized patients have a poor initial response to IV loop diuretics, and are considered diuretic “non-
responsive”. As a result of untreated fluid and sodium retention, worsening heart failure (WHF) occurs
frequently during their inpatient stay. Patients who develop WHF experience prolonged hospital lengths of stay
(LOS), increased mortality, and consume significantly more resources. There is an unmet need to individualize
diuretic therapy to improve decongestion and subsequently reduce adverse events. Yet, even knowing the
fundamental role of congestion in AHF, there is little consensus among clinicians about how to optimize
diuretic responsiveness. Despite multiple clinical trials aiming to clarify the ideal approach to loop diuretics in
the management of congestion, the appropriate selection of dose and route, as well as determination of
effectiveness of diuretic therapy remains largely empirical. A standardized, protocol-driven treatment pathway
for hospitalized patients started in the first two hours of ED evaluation and utilizing objective measures of
diuretic response is needed. This would maximize diuretic efficiency, facilitate quicker resolution of congestion,
avoid WHF and prolonged LOS, and reduce AHF readmissions. Our strong preliminary data suggests low
urine sodium predicts length of stay and outcomes after initial diuretic dosing in the outpatient and inpatient
setting, and can be used to titrate diuretics. Our preliminary use of spot urine sodium to titrate loop diuretic
doses and maximize response in inpatients with AHF has shown compelling improvements in congestion and
weight loss. We propose to begin this protocol in the ED and hypothesize it will improve AHF outcomes relative
to structured guideline-based usual care. Specifically, we hypothesize use of spot urine guided diuretic therapy
will: 1) result in significant improvement in global clinical status at 5 days relative to structured guideline-based
usual care, and 2) result in significant improvement in congestion at 5 days and in global rank at 30 days
relative to structured guideline-based usual care. Early protocolized tr...

## Key facts

- **NIH application ID:** 10102522
- **Project number:** 1R61HL155810-01
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** SEAN PATRICK COLLINS
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $881,233
- **Award type:** 1
- **Project period:** 2021-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10102522

## Citation

> US National Institutes of Health, RePORTER application 10102522, A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients with Acute Heart Failure (1R61HL155810-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10102522. Licensed CC0.

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