Acute Decompensated Heart FailureNCT04436718
Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
A study testing Daily pocus exam in people with Acute Decompensated Heart Failure, run by Riverside University Health System Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Daily pocus exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
RUHS Medical center
Moreno Valley, California, 92555
Michael Ulrich, 951-486-4640, m.ulrich@ruhealth.org
About this study
Official title: 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.
Read the 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
- Being tested
- Daily pocus exam
- Keywords
- Point of care ultrasound, Focused cardiac ultrasound, heart failure, inferior vena cava, POCUS, CHF, FCU, acute heart failure, decompensated heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily pocus examDiagnostic test
Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments
| Study group | Role | What they receive |
|---|---|---|
| Daily POCUS | Experimental | Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers. Receives: Diagnostic Test: Daily pocus exam |
| Usual care | No intervention | Patients are assessed daily by primary care providers per usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening renal failure
Serum Creatnine levels measured in mg/dL
Measured: During hospitalization typically one week
Secondary outcomes (1)
Length of stay
Measured in days from initial admission to discharge
Measured: During hospitalization typically one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Aug 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open label controlled trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ulrich MD, Riverside University Health System Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436718
- Sponsor's protocol ID
- 1374867-5
- Status last verified
- Jun 2020
- First submitted
- 20 Nov 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
- ClinicalTrials.gov ID
- NCT04436718
- Acronym / sponsor ID
- 1374867-5
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Point of care ultrasound, Focused cardiac ultrasound, heart failure, inferior vena cava, POCUS, CHF, FCU, acute heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open label controlled trial
| Arm | Type | Receives |
|---|---|---|
| Daily POCUS | Experimental | Diagnostic Test: Daily pocus examPatients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers. |
| Usual care | No intervention | –Patients are assessed daily by primary care providers per usual care. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily pocus examDaily evaluation of lung ultrasound for B line artifacts plus IVC assessments | Diagnostic test | Daily POCUS |
Primary outcome
Worsening renal failure
Time frame: During hospitalization typically one week
Serum Creatnine levels measured in mg/dL
1 secondary outcome
Length of stay
Time frame: During hospitalization typically one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily pocus exam in people with Acute Decompensated Heart Failure, run by Riverside University Health System Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Ulrich, MD (9514864640, m.ulrich@ruhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening renal failure (time frame: During hospitalization typically one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.