Comparison of two different medicines named Methylene Blue and Vasopressin for increasing blood pressure in patients with infection and low blood pressure

Efficacy and Safety of Methylene Blue Compared to Vasopressin as Second Vasopressor in the Management of Septic Shock in Adults: A Randomised Open Label Trial - MBVAP

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053979

Enrollment

Registered

2023-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: Methylene Blue: Methylene Blue 1mg/kg IV bolus followed by 0.5mg/kg/hour IV infusion for 6 hours Dose - 1mg/kg bolus followed by continuous infusion

Eligibility

Inclusion criteria

Inclusion criteria: 1. Septic Shock defined as suspected or proven infection and increase in qSOFA score of 2 or more from baseline, with lactate levels of >2mmol/L and requiring vasopressor agents to maintain a MAP more than 65mmHg despite adequate fluid resuscitation(guided by FALLS protocol) and 2. MAP 0.5 microgram per Kg per min.

Exclusion criteria

Exclusion criteria: 1. Age 2. Pregnant female 3. Undergoing palliative treatment or end-of-life care. 4. Post Cardiopulmonary Resuscitation(CPR) 5. Anuric( 6. Allergic to methylene blue 7. Patients of MAOI and SSRI 8. Known G6PD deficiency

Design outcomes

Primary

Measure	Time frame
Percentage of patients attaining a Mean Arterial Pressure of at least 65mmHg at 6 hours after starting Methylene Blue compared to VasopressinTimepoint: 6 hours	—

Secondary

Measure	Time frame
1.To Compare Responders between Methylene Blue and Vasopressin in terms of achieving a 10% reduction in the doses of Norepinephrine needed to maintain a MAP of 65mmHg in Septic shock adult patients. 2. Hemodynamic parameters (Heart rate, SBP, DBP, MAP till 6 hours) 3. Cumulative/ time-weighted average requirement of vasopressors (Noradrenaline, Vasopressin and Methylene Blue) 4. Lactate clearance at 6 hours. 5. Urine output (to be monitored during MB/ Vasopressin infusion on hourly basis till 6 hours. 6. To assess mortality rates at 24 hours and in-hospital mortality. 7. Safety of Methylene Blue in terms of hall in Hb from baseline, Methhemoglobinemia, worsening P/F ratio (till 6 hours). Timepoint: 6 hours, 24 hours and at hospital discharge / death	—

Measure

Time frame

1.To Compare Responders between Methylene Blue and Vasopressin in terms of achieving a 10% reduction in the doses of Norepinephrine needed to maintain a MAP of 65mmHg in Septic shock adult patients. 2. Hemodynamic parameters (Heart rate, SBP, DBP, MAP till 6 hours) 3. Cumulative/ time-weighted average requirement of vasopressors (Noradrenaline, Vasopressin and Methylene Blue) 4. Lactate clearance at 6 hours. 5. Urine output (to be monitored during MB/ Vasopressin infusion on hourly basis till 6 hours. 6. To assess mortality rates at 24 hours and in-hospital mortality. 7. Safety of Methylene Blue in terms of hall in Hb from baseline, Methhemoglobinemia, worsening P/F ratio (till 6 hours). Timepoint: 6 hours, 24 hours and at hospital discharge / death

—

Countries

India

Contacts

Public ContactDalim Kumar Baidya

AIIMS New Delhi

dalimkumar.ab8@gmail.com9871568534

Outcome results

None listed

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