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

Not Applicable

• Conditions: Acute Decompensated Heart Failure
• Interventions: Diagnostic Test: Daily pocus exam

• Registration Number: NCT04436718
• Lead Sponsor: Riverside University Health System Medical Center

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-11-20
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Study First Posted: 2020-06-18
• Last Update Posted: 2020-06-18
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily POCUS	Daily pocus exam	Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.

Primary Outcome Measures

Name	Time	Method
Worsening renal failure	During hospitalization typically one week	Serum Creatnine levels measured in mg/dL

Secondary Outcome Measures

Name	Time	Method
Length of stay	During hospitalization typically one week	Measured in days from initial admission to discharge

Trial Locations

Locations (1)

RUHS Medical center; 🇺🇸 Moreno Valley, California, United States