Acute Heart Failure, Heart Failure
Conditions
Keywords
Diuretic Therapy, Emergency Department
Brief 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.
Detailed 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.
Interventions
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Triple blinded study of guideline-based care compared with a protocolized diuretic strategy using urinary sodium
Intervention model description
Two-arm comparison of structured usual care vs urinary sodium guided diuresis
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Status Score | From the time of randomization through day 14 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient clinical congestion | from the time of randomization through the end of protocolized IV diuretics, approximately 14 days | Daily orthodema score |
| Cardiorenal Death and AHF Readmission | within 30 days of hospital discharge | Cardiorenal death and Acute Heart Failure Readmission |
| Global clinical status (GCS) | from the time of randomization through 14 days after randomization | measured daily using a continuous scale of 1-100 |
| Change in natriuretic peptides | from the time of randomization through the end of protocolized IV diuretics, approximately 14 days | Blood measurement |
| Net fluid loss | from the time of randomization through the end of protocolized IV diuretics, approximately 14 days | difference between fluid input and urine output in ml |
| Total urine output | from the time of randomization through the end of protocolized IV diuretics, approximately 14 days | cumulative urine output in ml |
| Weight Loss | from the time of randomization through the end of protocolized IV diuretics, approximately 14 days | cumulative weight loss in pounds |
| Home days | within 30 days from randomization | Those days not in the hospital, rehab or a skilled nursing facility from the time of randomization through day 30 |
| Subclinical ototoxicity | at two time points: 1) the day of randomization and 2) the next calendar day after protocolized IV diuretics are stopped | As measured by shoebox audiometry with a significant change in hearing threshold (dB) across frequencies from 250-8000 Hz |
| Cumulative natriuresis | from the time of randomization through the end of protocolized diuretics, approximately 14 days | cumulative sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium) |
| Average daily natriuresis | from the time of randomization through the end of protocolized diuretics, approximately 14 days | mean daily sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSean P. Collins, MD
Vanderbilt University Medical Center
Outcome results
None listed