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

Primary Purpose

Acute Decompensated Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily pocus exam
Sponsored by
Riverside University Health System Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Point of care ultrasound, Focused cardiac ultrasound, heart failure, inferior vena cava, POCUS, CHF, FCU, acute heart failure, decompensated heart failure

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RUHS Medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Daily POCUS

Usual care

Arm Description

Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.

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

Outcomes

Primary Outcome Measures

Worsening renal failure
Serum Creatnine levels measured in mg/dL

Secondary Outcome Measures

Length of stay
Measured in days from initial admission to discharge

Full Information

First Posted
November 20, 2019
Last Updated
June 15, 2020
Sponsor
Riverside University Health System Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04436718
Brief Title
Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
Official Title
Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riverside University Health System Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized open label controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daily POCUS
Arm Type
Experimental
Arm Description
Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients are assessed daily by primary care providers per usual care.
Intervention Type
Diagnostic Test
Intervention Name(s)
Daily pocus exam
Intervention Description
Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments
Primary Outcome Measure Information:
Title
Worsening renal failure
Description
Serum Creatnine levels measured in mg/dL
Time Frame
During hospitalization typically one week
Secondary Outcome Measure Information:
Title
Length of stay
Description
Measured in days from initial admission to discharge
Time Frame
During hospitalization typically one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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: Decline consent for study If admitted and research team not available for consent and initial evaluation prior within 6 hours of first diuretic administration Patients in whom diuretics will not be utilized (i.e. anuric, ESRD on HD) Inability to assess IVC (surgical anatomy, body habitus, Ileus, etc.) Patients admitted to ICU Patients currently on positive pressure ventilation (BiPAP) Patients discharged from the emergency department Patients discharged prior to evaluation by the POCUS team
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Ulrich, MD
Phone
9514864640
Email
m.ulrich@ruhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Minho Yu, DO
Phone
9514864640
Email
m.yu@ruhealth.org
Facility Information:
Facility Name
RUHS Medical center
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Ulrich
Phone
951-486-4640
Email
m.ulrich@ruhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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