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Methylene Blue as a Vasoplegic Syndrome preventive agent in cardiac surgeries

Phase 3
Recruiting
Conditions
Postoperative vasoplegic syndrome
H02.403.810.803
Registration Number
RBR-96ch27c
Lead Sponsor
Hospital das clínicas da Faculdade de Medicina da Universidade de São Paulo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Age 18 years or older; cardiac surgery with cardiopulmonary bypass; EUROSCORE II between 4% and 15%; patient undergoing double valve repair and/or double valve replacement surgery or reoperation in valve surgery or combined surgery (coronary bypass graft with valve surgery) or valve replacement due to endocarditis.

Exclusion Criteria

Refusal to participate in the study; patient involved in another clinical trial; emergency surgery; minimally invasive or transcatheter cardiac surgery; cardiac surgery with no cardiopulmonary bypass; change in surgical planning, such as single valve replacement/repair or isolated revascularization; previous or current use of selective serotonin reuptake inhibitor drugs, or selective and non-selective monoamine oxidase inhibitor drugs, or non-selective heterocyclic monoamine reuptake inhibitor drugs; patient with glucose-6-phosphate dehydrogenase deficiency or other hemolytic disease; previous history of hypersensitivity to methylene blue; acute liver dysfunction; pregnancy or potential risk of pregnancy; current use of vasoactive amines.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
A reduction in the average daily dosage of vasoactive agents is expected, calculated using a specific formula through the infusion rates records of vasoactive amines in postoperative balances, during the five days following the intervention. A reduction of 0.10 micrograms per kilogram per min in dosage is expected.
Secondary Outcome Measures
NameTimeMethod
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