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

NCT ID: NCT04436718

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-07-01

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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Daily pocus exam

Intervention Type: DIAGNOSTIC_TEST

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

Usual care

Patients are assessed daily by primary care providers per usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Daily pocus exam

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riverside University Health System Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Ulrich MD

Associate Medical Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RUHS Medical center

Moreno Valley, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Ulrich, MD

Role: CONTACT

m.ulrich@ruhealth.org

9514864640

Minho Yu, DO

Role: CONTACT

m.yu@ruhealth.org

9514864640

Facility Contacts

Michael Ulrich

Role: primary

m.ulrich@ruhealth.org

951-486-4640

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1374867-5

Identifier Type: -

Identifier Source: org_study_id