Clinical trial NCT03727282: Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiogenic Shock
Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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,
  * Cold extremities,
  * Reference of decrease of urine output,
  * Nausea, vomiting and food intolerance,
  * Presence of organic dysfunction

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: base excess levels
timeFrame: 24 hours
measure: bicarbonate levels
timeFrame: 24 hours
measure: systolic and diastolic blood pressure
timeFrame: 24 hours
measure: cardiac output
timeFrame: 24 hours
measure: systolic volume
timeFrame: 24 hours
measure: urinary output
timeFrame: 24 hours
measure: arterial lactate levels
timeFrame: 24 hours
measure: central venous oxygen saturation levels
timeFrame: 24 hours
measure: BNP levels
timeFrame: 24 hours
measure: troponin levels
timeFrame: 24 hours
measure: heart rate
timeFrame: 24 hours
measure: creatinine levels
timeFrame: 24 hours
measure: urea levels
timeFrame: 24 hours
Secondary outcomes:
measure: occurrence of sustained ventricular arrhythmia
timeFrame: 24 hours
measure: need for orotracheal intubation
timeFrame: 24 hours
measure: need for vasopressor or other inotropic association
timeFrame: 24 hours
measure: need for mechanical circulatory assistance
timeFrame: 24 hours
measure: lowering of consciousness level
timeFrame: 24 hours
measure: cardiorespiratory arrest
timeFrame: 24 hours
measure: worsening of renal function
timeFrame: 24 hours
measure: death
timeFrame: 24 hours
measure: failure of dobutamine weaning up
timeFrame: 7 days
measure: hospitalization time
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Unidade Clínica de Emergência
name: Mucio Tavares, MD
role: PRINCIPAL_INVESTIGATOR
References: