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Effect of methylene blue administered as a 6-Hour continuous infusion versus bolus injection with continuous infusion on ICU outcomes among patients with septic shock: a randomized, open-labelled, controlled trial

Effect of methylene blue administered as a 6-Hour continuous infusion versus bolus injection with continuous infusion on ICU outcomes among patients with septic shock: a randomized, open-labelled, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260329003
Enrollment
40
Registered
2026-03-29
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Septic shock requiring a norepinephrin Septic shock Methylene blue Catecholamine-sparing agent

Interventions

Methylene blue 100 mg was administered intravenously as a continuous infusion over 6 hours once daily, continued until vasopressor discontinuation or for a maximum of 72 hours.,Methylene blue was admi
Experimental Drug,Experimental Drug
6-Hour continuous infusion,Bolus injection with continuous infusion

Sponsors

Navamindradhiraj University Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age greater than or equal to 18 years 2.Diagnosis of septic shock according to Sepsis 3 criteria 3.Evidence of fluid unresponsiveness despite adequate fluid resuscitation assessed by at least one of the following procedures (CVP, PAOP, PLRT, IVC, PPV) 4.Receiving norepinephrine infusion at a dose greater than or equal to 0 point 2 mcg per kg per min with either mean arterial pressure MAP less than 65 mmHg or serum lactate greater than 2 mmol per L after at least 1 hour of norepinephrine administration prior to study enrollment

Exclusion criteria

Exclusion criteria: 1.Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, confirmed by G6PD screening test. 2.History of severe allergy to methylene blue. 3.Pregnancy, confirmed by urine pregnancy test in women of childbearing age or in those with amenorrhea. 4.Patients who refuse treatment or are in the terminal stage of illness (do-not-resuscitate [DNR] status or terminally ill).

Design outcomes

Primary

MeasureTime frame
Vasopressor duration Until vasopressor therapy is discontinued Number of hours / Determined from hospital records

Secondary

MeasureTime frame
Vasopressor-free days At 28 days post-intervention Number of days / Determined from hospital records,28-day hospital mortality At 28 days post-intervention Number of days / Determined from hospital records,Length of hospital stay Upon discharge post-intervention Number of days / Determined from hospital records,Length of ICU stray Upon discharge from ICU post-intervention Number of days / Determined from hospital records

Countries

Thailand

Contacts

Public ContactSupattra Chiewroongroj

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

supattra.c@nmu.ac.th022443000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026