Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
32 participants
INTERVENTIONAL
2020-03-10
2020-09-20
Brief Summary
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Detailed Description
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At the level of the micro-circulation, there is insufficient delivery of oxygen to organs and tissues which results in organ dysfunction and potential organ necrosis.One key factor leading to vascular dysfunction is the inappropriately increased production of nitric oxide within the blood vessel endothelium. Elevated levels of nitric oxide results in the blood vessel endothelium receiving direct vasodilator input, as well as the inability to respond to norepinephrine-mediated vasoconstriction. Nitric oxide activates the soluble isoform of the enzyme guanylatecyclase, which in turn increases production of cyclic guanosine monophosphate. Nitric oxide has other beneficial effects which are mediated via other pathways than guanylatecyclase; therefore, administration of a guanylate cyclase inhibitor such as methylene blue could be a safer therapeutic option than the inhibition of nitric oxide production.
These effects of methylene blue could be related to vasoconstriction and positive inotropic effects as well to an increase in blood volume, itself related to a decrease in vascular permeability. The use of methylene blue has been recently advocated as a potential adjunct in the treatment of shock states. However, the effect of MB at the level of the capillary bed, where vital exchange of oxygen and nutrients occurs, is unknown. Thus in this study, the investigators will investigate the effect of methylene blue in combination with NE at the microvascular level in septic shock.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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methylene blue group
The patients in this group will receive methylene blue bolus in addition to the norepinephrine infusion.
Methylene Blue
The patient will receive Methylene Blue bolus with a dose of 2 mg/kg over 10 minutes.
Norepinephrine infusion
The patient will receive norepinephrine infusion to maintain mean arterial pressure above 65 mmHg
Norepinephrine group
The patients in this group will receive norepinephrine infusion.
Norepinephrine infusion
The patient will receive norepinephrine infusion to maintain mean arterial pressure above 65 mmHg
Interventions
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Methylene Blue
The patient will receive Methylene Blue bolus with a dose of 2 mg/kg over 10 minutes.
Norepinephrine infusion
The patient will receive norepinephrine infusion to maintain mean arterial pressure above 65 mmHg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient is on norepinephrine infusion
Exclusion Criteria
* Pregnancy
18 Years
70 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Kareman Mohammad Saad Eldin Abd El Ghafar
Assistant lecturer of anesthesia and critical care medicine
Principal Investigators
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Ahmed Mukhtar, Professor
Role: PRINCIPAL_INVESTIGATOR
Professor of anesthesia
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N-13-2019
Identifier Type: -
Identifier Source: org_study_id
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