Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock

NCT ID: NCT03727282

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2021-01-02

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.

Conditions

Cardiogenic Shock; Heart Failure

Study Design

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

Study Groups

Liberal strategy

Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician

Group Type: OTHER

adjust dobutamine according to the attending physician

Intervention Type: PROCEDURE

adjust dobutamine dose

ejection volume index

Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index

Group Type: EXPERIMENTAL

adjust dobutamine according to the ejection volume index

Intervention Type: PROCEDURE

adjust dobutamine dose

Interventions

adjust dobutamine according to the ejection volume index

adjust dobutamine dose

Intervention Type: PROCEDURE

adjust dobutamine according to the attending physician

adjust dobutamine dose

Intervention Type: PROCEDURE

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

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

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mucio Tavares, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Clínica de Emergência

Central Contacts

Alexandre Soeiro, MD

Role: CONTACT

alexandre.soeiro@bol.com.br

1126615299

Other Identifiers

VTI-TAPSE

Identifier Type: -

Identifier Source: org_study_id