Microcirculatory Effects of Methylene Blue (MAGIC BLUE)

Civil Hospices of Lyon

Status: Completed

Conditions: Acute Circulatory Failure

Treatments: Other: Hemodynamic assessment (micro and macrocirculatory)

Study type: Observational

Funder types: Other

Identifiers

NCT04250389

2019_MAGICBLUE

Details and patient eligibility

About

International guidelines recommend Methylene Blue (MB) as a second-line drug in the treatment of norepinephrine refractory vasoplegic shock (VS) after Cardiopulmonary Bypass CPB. Macrocirculatory effects of MB in this setting are now well established but microcirculatory effects of MB remain unknown.

The purpose of this study is to assess the micro vascular effects of a single administration of methylene blue (1.5 mg/kg over 30 minutes) for norepinephrine-refractory VS post CPB.

Microcirculatory effect will be monitored before and one hour after MB infusion through cutaneous refill time, video microscopy measurements of the sublingual microcirculation and tissue oxygen saturation combined with vascular occlusion test (VOT).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients receiving methylene blue prescribed by the clinician in charge of the patient
• patient receiving a dose of norepinephrine > 0.5µg/kg/min
• normal or increase cardiac (> 2 L.min-1.m-2) at the time of inclusion
• vasoplegic syndrome post cardiopulmonary bypass for cardiac surgery

Exclusion criteria

• the need for hemodynamic intervention during the time of study (fluid resuscitation, introduction of inotropic or vasopressor support, change in inotropic support dose)
• age under 18 years

Trial design

25 participants in 1 patient group

Patients with VS receiving methylene blue infusion

Description:

The studied population will be all patients receiving methylene blue for refractory vasoplegic shock (VS) after Cardiopulmonary Bypass (CPB). Refractory VS is defined as follow: a dose of norepinephrine \> 0.5µg/kg/min to obtain a mean arterial pressure of 65-75 mmHg with a normal or increase cardiac (\> 2 L.min-1.m-2). Patients will be included in the investigator's 20-bed adult cardiothoracic intensive care unit (ICU) in a tertiary teaching hospital (Hopital Cardiologique Louis Pradel, Hospices Civils de Lyon).

Treatment:

Other: Hemodynamic assessment (micro and macrocirculatory)