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

Phase 2Active Not RecruitingNCT04481919

Vanderbilt University Medical Center474 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

474

Conditions

Heart Failure Acute Heart Failure

Interventions

Protocolized diuretic therapyDRUG

The urine sodium, urine creatinine and serum creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

VA Tennessee Valley Health Service

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Clinical Status Score

Daily composite of the clinical state and global clinical status (GCS), expressed as an integer ranging in value from 0 (deceased) to 15 (outpatient; best possible GCS).

Time frame: From the time of randomization through day 14

Secondary Outcomes

Inpatient clinical congestion

Daily orthodema score

Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days

Cardiorenal Death and AHF Readmission

Cardiorenal death and Acute Heart Failure Readmission

Time frame: within 30 days of hospital discharge

Global clinical status (GCS)

measured daily using a continuous scale of 1-100

Time frame: from the time of randomization through 14 days after randomization

Change in natriuretic peptides

Blood measurement

Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days

Net fluid loss

difference between fluid input and urine output in ml

Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days

Total urine output

cumulative urine output in ml

Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days

Data from ClinicalTrials.gov

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