Clinical trial NCT04436718: Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
Official title: Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: Point of care ultrasound
Focused cardiac ultrasound
heart failure
inferior vena cava
POCUS
CHF
FCU
acute heart failure
decompensated heart failure
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open label controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \>18 admitted for acute decompensated heart failure exacerbation as primary admission diagnosis from Emergency department to General Medicine ward that are administered diuretic therapy expected to be admitted for two days or more.

Exclusion Criteria:

1. Decline consent for study
2. If admitted and research team not available for consent and initial evaluation prior within 6 hours of first diuretic administration
3. Patients in whom diuretics will not be utilized (i.e. anuric, ESRD on HD)
4. Inability to assess IVC (surgical anatomy, body habitus, Ileus, etc.)
5. Patients admitted to ICU
6. Patients currently on positive pressure ventilation (BiPAP)
7. Patients discharged from the emergency department
8. Patients discharged prior to evaluation by the POCUS team

Primary outcomes:
measure: Worsening renal failure
timeFrame: During hospitalization typically one week
Secondary outcomes:
measure: Length of stay
timeFrame: During hospitalization typically one week
Other outcomes:
Locations:
city: Moreno Valley
country: United States
facility: RUHS Medical center
state: California
Study officials:
References: