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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RECRUITING
PHASE3
76 participants
INTERVENTIONAL
2024-08-05
2026-01-31
Brief Summary
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Detailed Description
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A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects.
In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on septic shock.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methylene Blue
Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution. Methylene Blue(1 mg/kg/IBW iv over 30min+0.25mg/kg/h x 6h) x 5-days/ discontinution of norepinephrine /ICU discharge (whichever occurred first).
Methylene Blue
Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution.The patient will receive Methylene Blue bolus with a dose of 1 mg/kg (Ideal Body Weight) over 30 minutes,followed by 0.25mg/kg/h as a continuous infusion for 6 hours for 5 days or discontinution of norepinephrine or until ICU discharge, whichever occurred first.
Placebo
5% dextrose solution in a volume to match experimental arm component.
Placebo
An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.
Interventions
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Methylene Blue
Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution.The patient will receive Methylene Blue bolus with a dose of 1 mg/kg (Ideal Body Weight) over 30 minutes,followed by 0.25mg/kg/h as a continuous infusion for 6 hours for 5 days or discontinution of norepinephrine or until ICU discharge, whichever occurred first.
Placebo
An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. diagnosis of septic shock within 12 h.
Exclusion Criteria
2. pregnant;
3. definitive pulmonary hypertension or chronic pulmonary heart disease;
4. known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
5. known allergy to methylene blue, phenothiazines, or food dyes;
6. anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
7. refusal of the attending staff or patient family;
8. participated in other study.
18 Years
90 Years
ALL
No
Sponsors
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Northern Jiangsu People's Hospital
OTHER
Responsible Party
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Qing-quan Lv
Principal Investigator
Principal Investigators
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Qingquan Lyu, Master
Role: PRINCIPAL_INVESTIGATOR
Northern Jiangsu People's Hospital
Locations
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Northern Jiangsu people's hospital
Yangzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024ky202
Identifier Type: -
Identifier Source: org_study_id
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