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methylene blue high dose for Septic Shock

Phase 2 & 3
Waitlist Available
Led By Ehab H Shaker, MD
Research Sponsored by National Cancer Institute, Egypt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

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 .

Eligible Conditions
  • Septic Shock

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Discontinuation of vasopressor
Secondary study objectives
Mortality

Trial Design

3Treatment groups
Active Control
Group I: methylene blue high doseActive Control2 Interventions
30 patients will receive a bolus of MB 4mg/kg in 100ml 0.9% Nacl over 20 minutes followed by continuous infusion of 0.25mg/kg/hour for 72 hours.
Group II: Normal salineActive Control2 Interventions
30 patients will receive placebo of 100ml 0.9% Nacl over 20 minutes followed by continuous infusion of Nacl for 72 hours.
Group III: methylene blue low doseActive Control2 Interventions
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.

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Who is running the clinical trial?

National Cancer Institute, EgyptLead Sponsor
108 Previous Clinical Trials
8,297 Total Patients Enrolled
Ehab H Shaker, MDPrincipal InvestigatorNational Cancer Institute (NCI)
10 Previous Clinical Trials
663 Total Patients Enrolled
~43 spots leftby Sep 2025
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