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?

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.

Study Overview

• Status: Unknown
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Diagnostic test: Daily pocus exam

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Ulrich, MD; Phone Number: 9514864640; Email: m.ulrich@ruhealth.org
• Study Contact Backup: Name: Minho Yu, DO; Phone Number: 9514864640; Email: m.yu@ruhealth.org

Study Locations

• United States
  • California
    • Moreno Valley, California, United States, 92555
      • Recruiting
      • RUHS Medical center
      • Contact: Michael Ulrich; Phone Number: 951-486-4640; Email: m.ulrich@ruhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Daily POCUS; Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.	Diagnostic test: Daily pocus exam; Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments
NO_INTERVENTION: Usual care; Patients are assessed daily by primary care providers per usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worsening renal failure	Serum Creatnine levels measured in mg/dL	During hospitalization typically one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Measured in days from initial admission to discharge	During hospitalization typically one week

Collaborators and Investigators

• Sponsor: Riverside University Health System Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: heart failure; CHF; Point of care ultrasound; acute heart failure; decompensated heart failure; Focused cardiac ultrasound; POCUS; inferior vena cava; FCU
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1374867-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes