ffect of methylene blue on hemodynamic and metabolic response in septic shock patient

Author(s):Show less -

Luis-Silva, Fabio ^{[1, 2]} ; Menegueti, Mayra Goncalves ^[3] ; Sepeda, Corina dos Reis ^[1] ; Petroski-Moraes, Bruno C. ^[1] ; Sato, Lucas ^[1] ; Peres, Leandro Moreira ^[1] ; Becari, Christiane ^[4] ; Basile-Filho, Anibal ^[1] ; Evora, Paulo R. B. ^[5] ; Martins-Filho, Olindo Assis ^[6] ; Auxiliadora-Martins, Maria ^[1]

Affiliation

^[1] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Surg & Anat, Div Intens Care Med, Ribeirao Preto - Brazil

^[2] Barao Maua Univ Ctr, Clin Med, Ribeirao Preto - Brazil

^[3] Univ Sao Paulo, Ribeirao Preto Nurse Sch, Ribeirao Preto - Brazil

^[4] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Surg & Anat, Div Vasc & Endovasc Surg, Ribeirao Preto - Brazil

^[5] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Surg & Anat, Div Cardiac Surg, Ribeirao Preto - Brazil

^[6] Fundacao Oswaldo Cruz, Rene Rachou Inst, FIOCRUZ Minas, Belo Horizonte, MG - Brazil

• Document type: Journal article
• Source: MEDICINE; v. 101, n. 3 JAN 21 2022.
• Web of Science Citations: 0

Abstract

Introduction: Septic shock is a lethal disease responsible for a large proportion of deaths in the Intensive Care Unit (ICU), even with therapy centered on fluid resuscitation, use of vasopressors and empirical antibiotic therapy applied within the first hour of diagnosis. Considering the multifactorial pathophysiology of septic shock and the mechanism of action of vasopressors, some patients may not respond adequately, which can lead to the maintenance of vasodilatation, hypotension and increased morbidity, and mortality. This protocol aims to verify whether the use of methylene blue in septic patients with an early diagnosis can contribute to an earlier resolution of a shock compared to standard treatment. Methods and analysis: This is a study protocol for a single-center randomized clinical trial design in an ICU of a tertiary university hospital. In this study, we intend to include 64 patients aged between 18 and 80 years with a diagnosis of septic shock, of any etiology, with up to 72 hours of evolution after volume restoration, using norepinephrine at a dose >= 0.2 mu g/kg/min and vasopressin at a dose of 0.04 IU/min. After the initial approach, we will randomize patients into two groups, standard care, and standard care plus methylene blue. The sample size was calculated in order to show 30% differences in septic shock resolution between groups. The Research Ethics Committee approved the study, and all patients included will sign an informed consent form (Clinical registration: RBR-96584w4). (AU)

• FAPESP's process: 18/26553-0 - A randomized, placebo-controlled study evaluating the hemodynamic and metabolic effects of Methylene blue treatment in septic shock
• Grantee: Maria Auxiliadora Martins
• Support Opportunities: Regular Research Grants