Cardiogenic ShockNCT03727282
Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock
A study testing adjust dobutamine according to the ejection volume index and adjust dobutamine according to the attending physician in people with Cardiogenic Shock and Heart Failure, run by University of Sao Paulo General Hospital.
Trial summary
Recent studies have suggested that the use of left ventricular ejection volume index calculation may aid in the hemodynamic management of critically ill patients. However, a prospective and randomized comparison in patients with heart failure for inotropic dose adjustment has not been described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Heart Failure
- What is being tested?
- adjust dobutamine according to the ejection volume index and adjust dobutamine according to the attending physician
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2019to 2 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF ≤ 40% documented on echocardiography
- BNP> 500 pg / mL
- Need for initiation of dobutamine and signs or symptoms of low cardiac output at admission defined by the presence of 2 or more of the following:
- SBP ≤ 95 mmHg
- FC> 100 bpm
- Peripheral vasoconstriction,
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- Cold extremities,
- Reference of decrease of urine output,
- Nausea, vomiting and food intolerance,
- Presence of organic dysfunction
Who cannot join
- Pregnancy.
- COPD
- Hepatical cirrhosis
- Atrioventricular block of 2nd or 3rd degree. and. SBP <80 mmHg or need for vasopressor.
- Use of definitive pacemaker.
- Body mass index greater than 40 kg / m2.
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- Use of oral anticoagulant.
- Acute coronary syndrome.
- Indication of use of another inotropic other than dobutamine.
- Orotracheal intubation.
- Presence of significant pericardial effusion.
- Obstruction of left ventricular outflow tract.
- Serum creatinine> 5.0 mg / dL or hemodialysis.
- Presence of 2 or more clinical / laboratory / radiological criteria of infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Transtoracic Ecocargiogram With Calculation of Left Ventricular Volume Index in the Initial Adjustment of Initial Dose of Dobutamine in Patients With Heart Failure and Cardiogenic Shock
Recent studies have suggested that the use of left ventricular ejection volume index calculation may aid in the hemodynamic management of critically ill patients. However, a prospective and randomized comparison in patients with heart failure for inotropic dose adjustment has not been described. The objective of this study was to evaluate the efficacy and safety of ejection volume index versus liberal strategy in adjusting dobutamine dose in patients with heart failure and low cardiac output. Methodology: A unicentric, randomized and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, dobutamine dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of ejection volume index is not inferior to the liberal strategy in the initial adjustment of the dose of dobutamine in patients with heart failure.
- Conditions
- Cardiogenic Shock, Heart Failure
- Being tested
- adjust dobutamine according to the ejection volume index, adjust dobutamine according to the attending physician
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjust dobutamine according to the ejection volume indexProcedure or surgery
adjust dobutamine dose
adjust dobutamine according to the attending physicianProcedure or surgery
adjust dobutamine dose
| Study group | Role | What they receive |
|---|---|---|
| Liberal strategy | Other | Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician Receives: Procedure: adjust dobutamine according to the attending physician |
| ejection volume index | Experimental | Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index Receives: Procedure: adjust dobutamine according to the ejection volume index |
What is being measured
The primary outcome is the main question the study is designed to answer.
base excess levels
serum analysis
Measured: 24 hours
bicarbonate levels
serum analysis
Measured: 24 hours
systolic and diastolic blood pressure
physical evaluation
Measured: 24 hours
cardiac output
echocardiography echocardiography
Measured: 24 hours
systolic volume
echocardiography
Measured: 24 hours
urinary output
urine analysis
Measured: 24 hours
arterial lactate levels
serum analysis
Measured: 24 hours
central venous oxygen saturation levels
serum analysis
Measured: 24 hours
BNP levels
plasma analysis
Measured: 24 hours
troponin levels
serum analysis
Measured: 24 hours
heart rate
physical evaluation
Measured: 24 hours
creatinine levels
serum analysis
Measured: 24 hours
urea levels
serum analysis
Measured: 24 hours
Secondary outcomes (10)
occurrence of sustained ventricular arrhythmia
electrocardiography
Measured: 24 hours
need for orotracheal intubation
Measured: 24 hours
need for vasopressor or other inotropic association
hipotension
Measured: 24 hours
need for mechanical circulatory assistance
Measured: 24 hours
lowering of consciousness level
glasgow < 14
Measured: 24 hours
cardiorespiratory arrest
Measured: 24 hours
worsening of renal function
increase 0.5 mg / dl in relation to admission creatinine
Measured: 24 hours
death
Measured: 24 hours
failure of dobutamine weaning up
Measured: 7 days
hospitalization time
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start2 Jan 2019 (estimated)
- Primary completion2 Jan 2020 (estimated)
- Study completion2 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mucio Tavares, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727282
- Sponsor's protocol ID
- VTI-TAPSE
- Status last verified
- Oct 2018
- First submitted
- 30 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transtoracic Ecocargiogram With Calculation of Left Ventricular Volume Index in the Initial Adjustment of Initial Dose of Dobutamine in Patients With Heart Failure and Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT03727282
- Acronym / sponsor ID
- VTI-TAPSE
- Conditions
- Cardiogenic Shock, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (estimated)
- Primary completion
- 2 Jan 2020 (estimated)
- Study completion
- 2 Jan 2021 (estimated)
- First posted
- 1 Nov 2018 (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.
Recent studies have suggested that the use of left ventricular ejection volume index calculation may aid in the hemodynamic management of critically ill patients. However, a prospective and randomized comparison in patients with heart failure for inotropic dose adjustment has not been described. The objective of this study was to evaluate the efficacy and safety of ejection volume index versus liberal strategy in adjusting dobutamine dose in patients with heart failure and low cardiac output. Methodology: A unicentric, randomized and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, dobutamine dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of ejection volume index is not inferior to the liberal strategy in the initial adjustment of the dose of dobutamine in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal strategy | Other | Procedure: adjust dobutamine according to the attending physicianInitiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician |
| ejection volume index | Experimental | Procedure: adjust dobutamine according to the ejection volume indexInitiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- LVEF ≤ 40% documented on echocardiography
- BNP> 500 pg / mL
- Need for initiation of dobutamine and signs or symptoms of low cardiac output at admission defined by the presence of 2 or more of the following:
Key exclusion criteria (14 listed)
- Pregnancy.
- COPD
- Hepatical cirrhosis
- Atrioventricular block of 2nd or 3rd degree. and. SBP <80 mmHg or need for vasopressor.
- Use of definitive pacemaker.
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 |
|---|---|---|
| adjust dobutamine according to the ejection volume indexadjust dobutamine dose | Procedure or surgery | ejection volume index |
| adjust dobutamine according to the attending physicianadjust dobutamine dose | Procedure or surgery | Liberal strategy |
Primary outcome
base excess levels
Time frame: 24 hours
serum analysis
bicarbonate levels
Time frame: 24 hours
serum analysis
systolic and diastolic blood pressure
Time frame: 24 hours
physical evaluation
cardiac output
Time frame: 24 hours
echocardiography echocardiography
systolic volume
Time frame: 24 hours
echocardiography
urinary output
Time frame: 24 hours
urine analysis
arterial lactate levels
Time frame: 24 hours
serum analysis
central venous oxygen saturation levels
Time frame: 24 hours
serum analysis
BNP levels
Time frame: 24 hours
plasma analysis
troponin levels
Time frame: 24 hours
serum analysis
heart rate
Time frame: 24 hours
physical evaluation
creatinine levels
Time frame: 24 hours
serum analysis
urea levels
Time frame: 24 hours
serum analysis
10 secondary outcomes
occurrence of sustained ventricular arrhythmia
Time frame: 24 hours
need for orotracheal intubation
Time frame: 24 hours
need for vasopressor or other inotropic association
Time frame: 24 hours
need for mechanical circulatory assistance
Time frame: 24 hours
lowering of consciousness level
Time frame: 24 hours
cardiorespiratory arrest
Time frame: 24 hours
worsening of renal function
Time frame: 24 hours
death
Time frame: 24 hours
failure of dobutamine weaning up
Time frame: 7 days
hospitalization time
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
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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.
Mucio Tavares, MD principal investigator
Unidade Clínica de Emergência
Questions about this trial
What is this clinical trial studying?
A study testing adjust dobutamine according to the ejection volume index and adjust dobutamine according to the attending physician in people with Cardiogenic Shock and Heart Failure, run by University of Sao Paulo General Hospital.
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 10 inclusion and 14 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Alexandre Soeiro, MD (1126615299, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
base excess levels (time frame: 24 hours). The study lists 13 primary outcomes in all. 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 1 Nov 2018.