Study Results
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Basic Information
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COMPLETED
25 participants
OBSERVATIONAL
2017-01-01
2019-06-30
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with VS receiving methylene blue infusion
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* age under 18 years
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service d'anesthesie reanimation, Hôpital cardiologique Louis Pradel
Bron, , France
Countries
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References
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Maurin C, Portran P, Schweizer R, Allaouchiche B, Junot S, Jacquet-Lagreze M, Fellahi JL. Effects of methylene blue on microcirculatory alterations following cardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2022 Apr 1;39(4):333-341. doi: 10.1097/EJA.0000000000001611.
Other Identifiers
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2019_MAGICBLUE
Identifier Type: -
Identifier Source: org_study_id