NCT04436718

Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?

Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Riverside University Health System Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Daily pocus exam	Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-06-18
• Last updated: 2020-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study