Will the early administration of methylene blue in intraabdominal sepsis patients with septic shock reduce the requirement of vasopressors - A randomized controlled trial

Effects of early administration of Methylene Blue in intraabdominal sepsis patients with septic shock - a randomized controlled trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/073013

Enrollment

120

Registered

2024-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: A09- Infectious gastroenteritis and colitis, unspecified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Methylene blue: An intravenous infusion of 100 mg of Methylene blue in 100 ml of 0.9% sodium chloride solution over 6 h ,once daily for a total of 3 doses will be administered.This will

Eligibility

Inclusion criteria

Inclusion criteria: 1)Adult patients above the age of 18 years 2)Admitted to the intensive care unit for more than 24 hours 3)Patients with septic shock (defined by Sepsis 3 criteria -highly suspected or confirmed infection, requiring noradrenaline to maintain a MAP more than or equal to 65 mmHg, and serum lactate more than 2 mmol per litre after adequate fluid resuscitation) 4)Patients who give written informed consent for data collection.

Exclusion criteria

Exclusion criteria: 1)Pregnancy 2)More than 48 hours since initiation of norepinephrine 3)High probability of death within 48 hours 4)Concurrent hemorrhagic, obstructive or hypovolemic shock 5)Major burn injury 6)Personal or familiar history of glucose-6-phosphate dehydrogenase deficiency 7)Allergy to methylene blue, phenothiazines, or food dyes 8)Recent intake (4-weeks) of selective serotonin re-uptake inhibitors 9)Refusal of the patient or decision maker to participate

Design outcomes

Primary

Measure	Time frame
To compare the change in mean VIS (vasoactive inotropic score) in both groups over the first seven days after enrollment into the study or until discharge from the ICU, whichever occurs earlier.Timepoint: At seven days after enrollment into the study or until discharge from the ICU, whichever occurs earlier.	—

Secondary

Measure	Time frame
1)Reduction in levels of inflammatory cytokine IL 6 & CRP 2)Reduction in number of vasopressor-free days at 30 days 3)All-cause mortality at 30 days 4)Reduction in days on mechanical ventilator 5)Reduction in length of stay in ICU & hospital 6)Reduction in SOFA score Timepoint: 1)After three days of methylene blue administration 2)At 30 days 3)At 30 days 4)At 30 days 5)At 30 days 6)At seven days after enrollment into the study or until discharge from the ICU, whichever occurs earlier.	—

Measure

Time frame

1)Reduction in levels of inflammatory cytokine IL 6 & CRP 2)Reduction in number of vasopressor-free days at 30 days 3)All-cause mortality at 30 days 4)Reduction in days on mechanical ventilator 5)Reduction in length of stay in ICU & hospital 6)Reduction in SOFA score Timepoint: 1)After three days of methylene blue administration 2)At 30 days 3)At 30 days 4)At 30 days 5)At 30 days 6)At seven days after enrollment into the study or until discharge from the ICU, whichever occurs earlier.

—

Countries

India

Contacts

Public ContactDr Isha hajara mohammad

All India Institute Of Medical Sciences,New Delhi

drrakesh.kumar.akb@gmail.com7838043581

Outcome results

None listed

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