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

Who is this study for? Patients in the emergency department with acute heart failure
What treatments are being studied? Protocolized diuretic therapy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
Tennessee
VA Tennessee Valley Health Service
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Sean P. Collins, MD
sean.collins@vumc.org
615-936-0253
Backup
Karen F. Miller, RN
615-936-4790
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 474
Treatments
Active_comparator: Protocolized spot urine sodium guided diuretic therapy
Patients will have a spot urine sodium and urine creatinine obtained. The urine and 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. Performed 3 times per day, diuretic dosing will be individualized based on the proportion of 24-hour diuresis achieved since the prior IV diuretic dose. Every 24 hours new goals for urine output and net negative fluid balance are established based on the study and treatment team's assessment of residual congestion until protocol completion.
No_intervention: Guideline-based care
Patients will be placed on guideline-based diuretic dosing consistent with usual practice. The initial dose will be two times their home dose and will be subsequently adjusted by the treating team based on renal function and symptom severity. The treating team can increase or decrease the frequency and dose of diuretic based on urine output and clinical assessment. Patients in this arm also have urine collected 3 times per day by the bedside nurse to mirror the intervention arm.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov