Methylene Blue and Microcirculation in Septic Shock
The Effect of Methylene Blue on Microcirculation in Patients With Septic Shock: a Randomized Controlled Trial
1 other identifier
interventional
32
1 country
1
Brief Summary
This trial aims to identify the effects of methylene blue infusion on the the micro-circulation in patients with septic shock. The investigators will evaluate various indices of micro-circulation such as: microvascular flow index, the flow heterogeneity index, the total vessel density, the perfused vessel density, and the proportion of perfused vessels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2020
CompletedMarch 5, 2020
March 1, 2020
6 months
March 3, 2020
March 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Microvascular flow index
The image will be divided into four quadrants and the vessels \<20 μ m diameter will be assigned a score based on the predominant flow characteristics of the vessels in that quadrant (0 = absent flow; 1 = intermittent; 2 = sluggish; 3 = normal). The values in each quadrant will be averaged to give an microvascular flow index for each sublingual site at each time point. To determine heterogeneity of perfusion, the flow heterogeneity index will be calculated as the highest microvascular flow index minus the lowest microvascular flow index divided by the mean microvascular flow index.
6 hours
Secondary Outcomes (9)
Total vessel density
6 hours
Perfused vessel density
6 hours
Proportion of perfused vessel
6 hours
mean arterial pressure
24 hours
serum lactate
6 hours
- +4 more secondary outcomes
Study Arms (2)
methylene blue group
EXPERIMENTALThe patients in this group will receive methylene blue bolus in addition to the norepinephrine infusion.
Norepinephrine group
ACTIVE COMPARATORThe patients in this group will receive norepinephrine infusion.
Interventions
The patient will receive Methylene Blue bolus with a dose of 2 mg/kg over 10 minutes.
The patient will receive norepinephrine infusion to maintain mean arterial pressure above 65 mmHg
Eligibility Criteria
You may qualify if:
- Septic shock
- The patient is on norepinephrine infusion
You may not qualify if:
- Elevated serum creatinine (above 1.4 mg/dL)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Mukhtar, Professor
Professor of anesthesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer of anesthesia and critical care medicine
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 5, 2020
Study Start
March 10, 2020
Primary Completion
September 10, 2020
Study Completion
September 20, 2020
Last Updated
March 5, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share