Microcirculatory Effects of Methylene Blue

NCT04250389 | Completed

• 1 other identifier: 2019_MAGICBLUE
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Methylene Blue

Outcome Measures

Primary Outcomes (1)

• Change in tissue oxygenation (resaturation speed expressed as %/sec) during the vessel obstruction test.

  The resaturation speed during reperfusion is defined as maximum StO2 - minimum StO2 /time of reperfusion. Tissue oxygen saturation (StO2) will be measured by near-infrared reflectance spectroscopy (NIRS) optode applied to the medial surface of the left or right forearm, 5 cm below the elbow. The sensor will be connected to the four-wavelength O3 Regional Oximetry device (Masimo Incorporation). All StO2 values will be recorded continuously and read every second. Data will be recorded online, transferred to a laptop with a specific software designed by Masimo (Masimo Instrument Configuration Tool (MICT) Version 1.0.4.9), and stored for further analysis. After completion of a baseline set of measurements for each patient, a vascular occlusion test (VOT) will be then perform using a manual pneumatic cuff inflator (Spengler SAS, Antony, France) positioned at the upper extremity of the ipsilateral upper limb.

  one hour after the start of methylene blue infusion

Secondary Outcomes (3)

• Video microscopy measurements of the sublingual microcirculation

  one hour after the start of methylene blue infusion

• Cutaneous and gingival refill time

  one hour after the start of methylene blue infusion

• Metabolic variables

  one hour after the start of methylene blue infusion

Study Arms (1)

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).

Other: Hemodynamic assessment (micro and macrocirculatory)

Interventions

Hemodynamic assessment (micro and macrocirculatory) OTHER

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.

Patients with VS receiving methylene blue infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients receiving methylene blue for refractory vasoplegic shock (VS) in intensive care unit after Cardiopulmonary Bypass CPB. Refractory VS was 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).

You may qualify if:

• patients receiving methylene blue prescribed by the clinician in charge of the patient
• patient receiving a dose of norepinephrine \> 0.5µg/kg/min
• vasoplegic syndrome post cardiopulmonary bypass for cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'anesthesie reanimation, Hôpital cardiologique Louis Pradel

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 34610607 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

FR (1)