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Methylene Blue as an early treatment for septic shock

Methylene Blue as an early Adjunctive treatment for septic shock-A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077795
Enrollment
120
Registered
2024-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I998- Other disorder of circulatory system

Interventions

Intervention1: METHYLENE BLUE: In septic shock patients, when Norepinephrine dose reached 0.20 mcg/kg/min, Vasopressin is initiated at 0.03IU/min, methylene blue is administered after test dose along

Sponsors

DR RISHWANTH RAJA P M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age greater than 18 years, 2)Highly suspected or confirmed infection 3)Norepinephrine dose greater than 0.2mcg/kg/min to maintain MAP greater than 65 mmHg 4)Less than 6 hrs of starting noradrenaline

Exclusion criteria

Exclusion criteria: 1)Pregnancy 2)Chronic kidney disease 3)Concurrent hemorrhagic, obstructive, cardiogenic, hypovolemic shock, 4)Greater than 24 hours of septic shock, History of glucose-6-phosphate dehydrogenase deficiency, 5)Allergy to methylene blue 6)Drug interactions: Phenothiazines, selective serotonin re-uptake inhibitors, Dapsone 7)Refusal of the patient or decision maker to participate.

Design outcomes

Primary

MeasureTime frame
To assess whether early adjunctive Methylene blue can reduce time to vasopressor discontinuation in patients with septic shockTimepoint: 7 days 14 days 21days

Secondary

MeasureTime frame
To assess the effects of continuous infusion of methylene blue on cardiac & renal SOFA scores, serum lactate levelsTimepoint: 24 hours 48 hours 72 hours

Countries

India

Contacts

Public ContactDr Rishwanth Raja P M

Sri Ramachandra Institute of Higher Education and Research

hod.criticalcare@sriramachandra.edu.in8056126336

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026