Clinical trial · Interventional
Low Dose Versus High Dose Methylene Blue in Septic Patients
Comparative Study Between High and Low Dose Methylene Blue Infusion in Septic Cancer Patients. A Randomized Blinded Controlled Study
NCT06005558CI-TRIAL-00078569completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main aim of this study is to examine the various effects of continuous methylene blue infusion in septic cancer patients and to compare it with the traditional infusion of noradrenaline in such patients .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Septic Shock | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylene Blue high dose | Drug | — | UNRESOLVED |
| Methylene Blue low dose | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Normal saline
- description
- 30 patients will receive placebo of 100ml 0.9% Nacl over 20 minutes followed by continuous infusion of Nacl for 72 hours.
- interventionNames
- Drug: Methylene Blue low dose
- Drug: Methylene Blue high dose
- type
- ACTIVE_COMPARATOR
- label
- methylene blue low dose
- description
- 30 patients will receive a bolus of MB 1mg/kg in 100ml 0.9% Nacl over 20 minutes followed by continuous infusion of 0.25mg/kg/hour for 72 hours.
- interventionNames
- Drug: Normal saline
- Drug: Methylene Blue high dose
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥ 18 years and ≤ 65 with septic shock as defined by Sepsis-3 criteria (confirmed infection, requiring vasopressor to maintain a mean arterial blood pressure (MAP) ≥ 65 mmHg, and serum lactate \> 2 mmol/L after adequate fluid resuscitation), and requiring mechanical ventilation. Exclusion Criteria: * myocardial infarction or cerebrovascular accident within the last 3 months. * severe lung , liver or kidney disease (creatinine \>3.5 mg/dL). * pregnancy. * glucose 6-phosphate-dehydrogenase deficiency. * known allergy to MB or food dyes and the use of nitrates within the last 3 days. * more than 24 hrs since initiation of norepinephrine. * other causes of shock than sepsis . * recent intake (4-weeks) of selective serotonin re-uptake inhibitors or MAOi. * refusal of the patient guardian to participate.
References
Publications (2)
- RESULTChalise SN, Sahib TA, Boyer GA, Pathak V. Methylene Blue in Refractory Shock. Cureus. 2022 Nov 6;14(11):e31158. doi: 10.7759/cureus.31158. eCollection 2022 Nov. PMID 36505110
- DERIVEDShaker EH, Soliman AM, Bedewy AAE, Elrawas MM. Comparative study between high and low dose methylene blue infusion in septic cancer patients: a randomized, blinded, controlled study. BMC Anesthesiol. 2025 Jan 8;25(1):15. doi: 10.1186/s12871-024-02792-3. PMID 39780053