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Clinical outcomes of septic shock patients receiving methylene blue with vasopressor catecholamine versus catecholamine alone: A randomized controlled trial

Clinical outcomes of septic shock patients receiving methylene blue with vasopressor catecholamine versus catecholamine alone: A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251007014
Enrollment
48
Registered
2025-10-07
Start date
2025-01-02
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

Early administration of methylene blue in patients with septic shock who require vasopressor support septic shock, methylene blue

Interventions

Drug and Dose: Methylene blue 100 mg Dilution: In 500 mL 5 percent dextrose in water Infusion rate: Over 6 hours Frequency and Duration: Once daily for three consecutive days or until vasopressors
Methylene blue,Control group

Sponsors

Thanapat Tantraporn
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 Central venous pressure CVP 8 to 12 mmHg measured via central venous catheter Pulmonary artery occlusive pressure PAOP greater than 18 mmHg with cardiac index CI greater than 2 point 2 L per min per m2 measured via pulmonary artery catheter Passive leg raising test PLRT negative defined as less than 15 percent increase in cardiac output after PLRT Inferior vena cava IVC collapsibility index less than 40 percent on ultrasonography in patients not on mechanical ventilation IVC distensibility index less than 18 percent on ultrasonography in mechanically ventilated patients ultrasonography performed by resident physician with no conflict of interest in this study Pulse pressure variation PPV less than 15 percent on arterial blood pressure monitoring ABPM 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 ContactThanapat Tantraporn

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

thanapat.tan@nmu.ac.th022443000

Outcome results

None listed

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