Acute Circulatory FailureMAGIC BLUENCT04250389
Microcirculatory Effects of Methylene Blue
An observational study of Acute Circulatory Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Circulatory Failure
- What is being tested?
- Hemodynamic assessment (micro and macrocirculatory)
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service d'anesthesie reanimation, Hôpital cardiologique Louis Pradel
Bron, 69500
About this study
Official title: Microcirculatory Effects of Methylene Blue in Vasoplegic Shock After Cardiopulmonary Bypass: a Pilot Study
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
- Being tested
- Hemodynamic assessment (micro and macrocirculatory)
- Keywords
- Methylene Blue
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Hemodynamic assessment (micro and macrocirculatory) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour after the start of methylene blue infusion
Secondary outcomes (3)
Video microscopy measurements of the sublingual microcirculation
Proportion of Perfused Vessel (PPV), Total Vessel Density (TVD), Perfused Vessel Density (PVD), Microcirculatory Flow Index (MFI) and heterogeneity index will be reported. Video microscopy measurements will be collected before and one hour after the beginning of MB infusion.
Measured: one hour after the start of methylene blue infusion
Cutaneous and gingival refill time
Five consecutive cutaneous recoloration time (CRT) acquisitions on the thorax and five consecutive gingival recoloration time (GRT) acquisitions will be made after calibrated compression of the skin and the gingiva. These measurements will be collected before and one hour after the beginning of MB infusion.
Measured: one hour after the start of methylene blue infusion
Metabolic variables
Arterial blood gases including arterial lactate and central venous blood gases will be withdrawn before and one hour after the beginning of MB infusion concomitantly to measurement of cardiac output to allow calculation of oxygen delivery (DO2), oxygen uptake (VO2), oxygen extraction ratio (ER), venous-to-arterial difference in carbon dioxide partial pressure (PCO2gap), modified respiratory quotient (RQ modified) and ratio of central venous-to-arterial carbon dioxide content to arteriovenous oxygen content (DavCO2/DavO2).
Measured: one hour after the start of methylene blue infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2017
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Circulatory FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250389
- Sponsor's protocol ID
- 2019_MAGICBLUE
- Acronym
- MAGIC BLUE
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34610607
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Effects of Methylene Blue in Vasoplegic Shock After Cardiopulmonary Bypass: a Pilot Study
- ClinicalTrials.gov ID
- NCT04250389
- Acronym / sponsor ID
- MAGIC BLUE / 2019_MAGICBLUE
- Conditions
- Acute Circulatory Failure
- Keywords
- Methylene Blue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with VS receiving methylene blue infusion | – | Other: Hemodynamic assessment (micro and macrocirculatory)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with VS receiving methylene blue infusion |
Primary outcome
Change in tissue oxygenation (resaturation speed expressed as %/sec) during the vessel obstruction test.
Time frame: one hour after the start of methylene blue infusion
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.
3 secondary outcomes
Video microscopy measurements of the sublingual microcirculation
Time frame: one hour after the start of methylene blue infusion
Cutaneous and gingival refill time
Time frame: one hour after the start of methylene blue infusion
Metabolic variables
Time frame: one hour after the start of methylene blue infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 34610607Maurin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Circulatory Failure, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tissue oxygenation (resaturation speed expressed as %/sec) during the vessel obstruction test. (time frame: one hour after the start of methylene blue infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.