A study on the effect of a specific medicine (Methylene Blue) in treating patients with low blood pressure

Methylene bluE aNd Time tO Resolution of Septic Shock (MENTORS): an open label randomized trial - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064309

Enrollment

Registered

2024-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system Health Condition 2: C00-D49- Neoplasms

Interventions

Intervention1: Methylene blue: Methylene blue will be administered at a dose of 2 mg/kg for 1 hour, followed by 0.5mg/kg for 24 hours. Each patient will receive this treatment once after recruitment i

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults admitted to the ICU with refractory septic shock with hypotension (MAP below 65 mm Hg OR diastolic BP below 60 mm Hg) despite fluid resuscitation and use of vasopressors – noradrenaline more than or equal to 0.25 mcg/kg/min and vasopressin at 0.04 IU/min. 2. Consent from the LAR to participate in the study

Exclusion criteria

Exclusion criteria: 1. Known allergy to methylene blue 2. Known G6PD deficiency or any hemolytic disorder 3. Pre-existing cardiovascular disease 4. Previously recorded ejection fraction lesser than 40 percent 5. Patients with survival expectancy less than 24 hours 6. Patients whose LAR refuse consent

Design outcomes

Primary

Measure	Time frame
Time to resolution of shockTimepoint: Until death or ICU discharge	—

Secondary

Measure	Time frame
2. Response to methylene blue therapy will be defined as increase in mean arterial pressure by 10 percent and (or) or reduction in dosage requirement of other vasopressor medication. Mean arterial pressure recordings will be measured using radial or femoral arterial lines. This will be recorded at the start of infusion, at 1 hour, 12 hours, 24 hours and 96 hours after initiation of the infusion of the study drug following randomization. 3. ICU and hospital mortality 4. Duration of vasopressor therapy and vasopressor-free days 5. Duration of invasive mechanical ventilation and ventilator-free days 6. Delta SOFA score 7. Need for renal replacement therapy and RRT free days 8. Any possible adverse effects to methylene blue: Methylene blue has been used extensively without any adverse effects. Timepoint: Until death or ICU discharge	—

Measure

Time frame

2. Response to methylene blue therapy will be defined as increase in mean arterial pressure by 10 percent and (or) or reduction in dosage requirement of other vasopressor medication. Mean arterial pressure recordings will be measured using radial or femoral arterial lines. This will be recorded at the start of infusion, at 1 hour, 12 hours, 24 hours and 96 hours after initiation of the infusion of the study drug following randomization. 3. ICU and hospital mortality 4. Duration of vasopressor therapy and vasopressor-free days 5. Duration of invasive mechanical ventilation and ventilator-free days 6. Delta SOFA score 7. Need for renal replacement therapy and RRT free days 8. Any possible adverse effects to methylene blue: Methylene blue has been used extensively without any adverse effects. Timepoint: Until death or ICU discharge

—

Countries

India

Contacts

Public ContactDr Akshaya Ramaswami

Tata Memorial Hospital

kaivalyaak@yahoo.co.in9869077526

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026