None listed
Conditions
Brief summary
Urinary sodium (UNa) enables rapid assessment of the response to diuretic therapy. If inadequate, it allows for rapid escalation of the diuretic dose until adequate diuresis is achieved. Insufficient decongestive therapy in acute heart failure (AHF) is associated with poor outcomes. Hence, spot urinary sodium concentration (UNa) has been proposed as a tool to rapidly assess the response to decongestive therapy and to estimate future outcomes by the Heart Failure Association of the European Society of Cardiology in 2019 and incorporated in the 2021 European Society of Cardiology Guidelines for the diagnosis and treatment of AHF. This recommendation is entirely based on expert opinion, and the efficacy of this approach has not been tested in a randomised controlled trial (RCT). In this prospective RCT, we investigate the clinical utility of spot UNa measures in the treatment of patients with AHF, and its effect on the short-term and long-term clinical outcomes compared with the standard treatment. Primary Aim is to determine if titrating intravenous loop diuretic dosing based on serial spot UNa samples (intervention arm) compared with diuretic dose titration based on the evolution of clinical signs and symptoms (standard care arm) leads to a shorter length of stay in patients hospitalised with AHF. Secondary aims are to determine if Una-guided loop diuretic titration is associated with: (1) Greater weight loss and decongestion at 72 hours. (2) Less adverse effects during admission (3) Improved all-cause mortality and unplanned readmissions at 30 days, 6 months, 12 months, and 2 years (4) Better prediction of the risk of adverse events, death and readmissions compared with standard care.
Interventions
Urinary sodium (UNa) will be obtained from acute heart failure (AHF) patients admitted to the hospital within 6 hours after the commencement of loop diuretic therapy and then twice a day to adjust the dose of intravenous diuretics. The efficacy of this approach in adjusting the dose of intravenous diuretic in AHF patients will be compared to current standard methods (weight change and net fluid balance).
- Ward staff will obtain the urinary samples from patients. Investigators (cardiologists) wi
Urinary sodium (UNa) will be obtained from acute heart failure (AHF) patients admitted to the hospital within 6 hours after the commencement of loop diuretic therapy and then twice a day to adjust the dose of intravenous diuretics. The efficacy of this approach in adjusting the dose of intravenous diuretic in AHF patients will be compared to current standard methods (weight change and net fluid balance). - Ward staff will obtain the urinary samples from patients. Investigators (cardiologists) will adjust the dose of diuretic. - There will be a timetable in each patient's chart about the timing of urine sample collection that should be completed by nursing staff and will be monitored by investigators of the study.
Sponsors
Metro North Health, The Prince Charles Hospital (TPCH)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: greater than or equal to 18 years 2. admitted under cardiology team with primary diagnosis of AHF, requiring intravenous diuretic therapy
Exclusion criteria
1. Hemodynamically unstable patients requiring inotropic or mechanical circulatory support 2. Severe kidney dysfunction 3. Patients on dialysis or anuric at presentation 4. Patients on high-dose oral diuretic before admission 5. Patients transferred from another hospital 6. Unable to provide informed consent
Outcome results
None listed