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

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436718
• Other study ID #: 1374867-5
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2020
• Source: Riverside University Health System Medical Center
• Contact: Michael Ulrich, MD
• Phone: 9514864640
• Email: m.ulrich[@]ruhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Diagnostic Test:
• Daily pocus exam
Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments

Locations

Country	Name	City	State
United States	RUHS Medical center	Moreno Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Riverside University Health System Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worsening renal failure	Serum Creatnine levels measured in mg/dL	During hospitalization typically one week
Secondary	Length of stay	Measured in days from initial admission to discharge	During hospitalization typically one week