A study in patients with septic shock to compare the effect of two different doses of methylene blue on reducing the need of blood pressure increasing medicine (vasopressors)

Comparison of two different doses of methylene blue as an adjunctive in patients with septic shock: A randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/08/093217

Enrollment

100

Registered

2025-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: B95-B97- Bacterial and viral infectious agents

Interventions

Intervention1: Methylene Blue as an adjuvant to vasopressors in patient with septic shock: All the patients admitted in ICU with a diagnosis of septic shock and on vasopressors will receive intravenou

Eligibility

Inclusion criteria

Inclusion criteria: Patient having body weight 50 - 70 kg with septic shock as defined by sepsis 3 criteria - highly suspected or confirmed infection, requiring norepinephrine to maintain a mean arterial pressure more than or equal to 65 mmHg and serum lactate more than 2 mmol/L after adequate fluid resuscitation.

Exclusion criteria

Exclusion criteria: More than 24 hours since initiation of norepinephrine Pregnancy High probability of death within 48 hours Concurrent hemorrhagic, obstructive or hypovolemic shock Refusal of the patient or decision maker to participate Pending damage control surgery Major burn surgery History of glucose 6 phosphate dehydrogenase deficiency Allergy to methylene blue, phenothiazines or food dyes Recent intake (less than 4 weeks) of selective serotonin re-uptake inhibitors

Design outcomes

Primary

Measure	Time frame
Compare the time taken to vasopressor discontinuation after starting of methylene blueTimepoint: From start of methylene blue infusion till day 7	—

Secondary

Measure	Time frame
Total duration of vasopressor supportTimepoint: From start of vasopressor administration until cessation;Serum lactate clearanceTimepoint: at 24 hour, 48 hour and 72 hour after starting of vasopressors;Incidence of vasopressin requirementTimepoint: At 24hr, 48hr & 72hr after starting the methylene blue till day 7;Adverse event such as Hemolysis, Serotonin Syndrome, Cyanosis, Nausea, Vomiting, ArrhythmiasTimepoint: At 24hr, 48hr & 72hr after starting the methylene blue till the day 7;ICU length of stayTimepoint: Time duration for which patients remain in ICU;28 days all cause mortalityTimepoint: Mortality till 28 days after starting of vasopressors	—

Measure

Time frame

Total duration of vasopressor supportTimepoint: From start of vasopressor administration until cessation;Serum lactate clearanceTimepoint: at 24 hour, 48 hour and 72 hour after starting of vasopressors;Incidence of vasopressin requirementTimepoint: At 24hr, 48hr & 72hr after starting the methylene blue till day 7;Adverse event such as Hemolysis, Serotonin Syndrome, Cyanosis, Nausea, Vomiting, ArrhythmiasTimepoint: At 24hr, 48hr & 72hr after starting the methylene blue till the day 7;ICU length of stayTimepoint: Time duration for which patients remain in ICU;28 days all cause mortalityTimepoint: Mortality till 28 days after starting of vasopressors

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Countries

India

Contacts

Public ContactNitin Kumar

Indira Gandhi Institute of Medical Sciences

kumarnitin516@gmail.com08076070302

Outcome results

None listed

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