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This study evaluates daily POCUS/FCU exams on patients admitted for acute decompensated heart failure with primary end point of acute kidney injury while in hospital.
Patients with admitted to hospital with Acute Decompensated Heart failure (ADHF) suffer a significant morbidity and premature mortality. Administration of intravenous (IV) diuretics is largely guided by clinical judgment based on physical exam, net fluid measurement, changes in daily weights and chest x-ray findings. The key objective is to promote adequate diuresis while improving symptoms, without compromising renal function. Laboratory tests demonstrating hemo-concentration, increasing BUN, and increasing creatinine have been proposed as positive prognostic indicators in patients receiving IV diuretic therapy but these methods suffer from inadequate predictive value. Observational studies have identified worsening renal failure (WRF) in patients admitted for heart failure as an important clinical entity associated with worsening clinical outcomes.
Point of care Ultrasound (POCUS) has the potential to fill an unmet need for monitoring patients recieving IV diuretic therapy. POCUS provides clinicians with immediate diagnostic information obtained and interpreted at bedside that can augment and enhance the physical examination. Numerous studies have examined POCUS assessment of pulmonary edema and measurement of the Inferior Vena Cava (IVC) to estimate hemodynamic parameters for patients with acute decompensated heart failure (ADHF). No study to date has examined POCUS effect on clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily POCUS | Experimental | Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers. |
|
| Usual care | No Intervention | Patients are assessed daily by primary care providers per usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily pocus exam | Diagnostic Test | Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Worsening renal failure | Serum Creatnine levels measured in mg/dL | During hospitalization typically one week |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Measured in days from initial admission to discharge | During hospitalization typically one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Ulrich, MD | Contact | 9514864640 | m.ulrich@ruhealth.org | |
| Minho Yu, DO | Contact | 9514864640 | m.yu@ruhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RUHS Medical center | Recruiting | Moreno Valley | California | 92555 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2019 | Jun 15, 2020 |
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Randomized open label controlled trial
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| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2019 | Jun 15, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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