MedTrace Logo

Microcirculatory Effects of Methylene Blue

NCT04250389 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2020-01-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-01-01
Completion
2019-06-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250389 on ClinicalTrials.gov