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The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care.
The main questions it aims to answer are:
Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice.
Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.
Patients will be randomized into one of three groups: 50 micromolar natriuresis, 85 micromolar natriuresis, and standard of care. The natriuresis arms will have urine sodium assessed two to four hours administration of intravenous diuretics. If the natriuretic response is inadequate they will immediately receive a higher dose of diuretic. This process will be repeated for the first 72 hours of admission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Traditional diuretic dosing adjustment per provider |
|
| 50 mmol/L urine sodium | Experimental | Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L |
|
| 85 mmol/L urine sodium | Experimental | Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide intravenous solution | Drug | Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| Natriuresis at 24 hours | 24-hour natriuresis as measured by urine sodium in a 24-hour urine collection | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Natriuresis at 48 hours | Total urine sodium assessed by 24-hour urine collection | 48 hours after enrollment in trial |
| Diuresis at 24 hours | Total urine volume assessed by 24 hour collection |
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Inclusion Criteria:
The study will target adults 18 years of age or older admitted to Lakeland Regional Medical Center who:
Have a primary diagnosis of acute decompensated heart failure, and
Have at least one of the following signs of hypervolemia:
Exclusion Criteria:
Exclusion criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Lurie, DO | Contact | 8636871100 | 1443 | Andrew.Lurie@myLRH.org |
| Anas Bizanti, MD | Contact | 8636871100 | 1443 | anas.bizanti@mylrh.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Lurie, DO | Lakeland Regional Hospital | Study Director |
| Anas Bizanti, MD | Lakeland Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeland Regional Hospital | Recruiting | Lakeland | Florida | 33805 | United States |
Yes
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| Furosemide intravenous solution | Drug | Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L |
|
|
| Furosemide intravenous solution | Drug | Standard of care |
|
|
| 24 hours after enrollment |
| Diuresis at 48 hours | Total urine volume assessed via 24-hour collection | 48 hours after enrollment |
| Length of Stay | Duration of hospitalization | From the date and time of admission order until the date and time of discharge order, assessed for each participant up to 30 days after admission or death from any cause, whichever comes first. |
| Readmission of any cause at 30 days | Proportion of participants who experience an unplanned hospital readmission for any cause within 30 days after the index hospital discharge. | 30 days after discharge |
| Readmission rate of any cause at 90 days | Proportion of participants who experience an unplanned hospital readmission for any cause within 90 days after the index hospital discharge. | 90 days after the time of discharge |
| Readmission rate of Heart failure | Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 30 days after the index hospital discharge. | 30 days |
| Readmission rate for heart failure | Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 90 days after the index hospital discharge. | 90 days |
| Weight change | Difference in weight from admission compared to discharge | Weight assessed at baseline within 24 hours of hospital admission and at discharge, with the discharge weight measured on the discharge day up to 30 days after admission. |
| Net fluid balance | Cumulative difference between total fluid intake and output during the hospitalization | Net fluid balance assessed from baseline Day 1 of admission through hospital discharge, with discharge assessment on the discharge day up to 30 days after admission. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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