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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04436718
Enrollment
400
Registered
2020-06-18
Start date
2019-08-01
Completion date
2021-07-01
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIAGNOSTIC_TESTDaily pocus exam

Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments

Sponsors

Riverside University Health System Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized open label controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Worsening renal failureDuring hospitalization typically one weekSerum Creatnine levels measured in mg/dL

Secondary

MeasureTime frameDescription
Length of stayDuring hospitalization typically one weekMeasured in days from initial admission to discharge

Countries

United States

Contacts

Primary ContactMichael Ulrich, MD
m.ulrich@ruhealth.org9514864640
Backup ContactMinho Yu, DO
m.yu@ruhealth.org9514864640

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026