NCT04250389

Microcirculatory Effects of Methylene Blue

Microcirculatory Effects of Methylene Blue in Vasoplegic Shock After Cardiopulmonary Bypass: a Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Acute Circulatory Failure

Interventions

Type	Name	Description
OTHER	Hemodynamic assessment (micro and macrocirculatory)	Each of the variable related to macro- and microcirculatory will be evaluated before and one hour after start of MB infusion. Macrocirculatory parameters will include : * Mean, systolic, diastolic arterial, heart rate (HR) * Cardiac output (CO), sequential vascular response (SVR) and stroke volume (obtained with transthoracic echocardiography or transpulmonary thermodilution catheter if available). * A passive leg raising (PLR) test will be performed before and one hour after MB infusion. Patients will be classified as fluid responder if they had a CO of at least 10% after PLR. Microcirculatory parameters will include : * Cutaneous and gingival refill time * Tissue oxygen saturation combined with vascular occlusion test (VOT) * Video microscopy measurements of the sublingual microcirculation * Metabolic variables: Arterial blood gases including arterial lactate and central venous blood gases.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-01-01
• Completion: 2019-06-01
• First posted: 2020-01-31
• Last updated: 2020-01-31

Locations

1 site across 1 country: France