Postoperative vasoplegic syndrome
Conditions
Interventions
292 participants with a high probability for postoperative vasoplegic syndrome will be selected and assigned to two groups, an intervention group (146) and a control group (146), on the day before sur
Sponsors
Hospital das clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| A reduction in arterial lactate levels is expected, which is measured through the collection of arterial blood gases using an enzymatic colorimetric measurement technique, with an expected difference of 0.4 mmol/L. The worst daily value will be considered, being monitored for the period between the day of the intervention and 5 days afterwards.;It is expected An increase in mean arterial pressure levels in mmHg, measured using an invasive technique and collected by standardized Nihon Khoden monitor records, with a difference in value of 10 mmHg expected. The data taken into account for this outcome will come from the intraoperative period, after the administration of the intervention.;A reduction in the incidence of vasoplegic syndrome, diagnosed according to combined clinical, hemodynamic via pulmonary artery catheter and echocardiographic criteria, is expected. An estimated 26% reduction in the occurrence of new cases is expected. This outcome will be monitored during the 30-day perioperative period.;A reduction in the incidence of low cardiac output syndrome, diagnosed according to combined clinical, hemodynamic via pulmonary artery catheter and echocardiographic criteria, is expected. An estimated 30% reduction in the occurrence of new cases is expected. This outcome will be monitored during the 30-day perioperative period.;A reduction in the need for transfusion of packed red blood cells, measured by units of blood components transfused, is expected, with an expected drop in the average of around 1.1 units. This outcome will be monitored at the time of surgery.;A decrease in the incidence of need for reoperation is hypothesized, with a reduction of 2 events. The criteria for defining "reoperation" are those of the Society of Thoracic Surgeons. This outcome will be monitored for 30 days after the intervention.;A reduction in the incidence of acute renal dysfunction is expected, identified by the KDIGO (Kidney Disease Improving Global Outcomes) criteria, with a d | — |
Countries
Brazil
Contacts
Public ContactJosé Otávio Auler Júnior
Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed