Trial · Interventional

CompletedPhase 2/3Registry data

Low Dose Versus High Dose Methylene Blue in Septic Patients

NCTNCT06005558Other idMethylene blue

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 90 participants (actual)
Sponsor: National Cancer Institute, Egypt · Other
Design: Randomized · Double masking
Countries: 1 country
Egypt
Start: 1 Aug 2023
Primary completion: 29 Apr 2024
Completion: 15 May 2024
First posted: 22 Aug 2023
Last update posted: 5 Jul 2024
Conditions: Septic Shock

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 2/3
Low Dose Versus High Dose Methylene Blue in Septic Patients
NCT06005558
1 Aug 2023 to 15 May 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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 .

Interventions

Normal salineDrug
Methylene Blue low doseDrug
Methylene Blue high doseDrug

Arms3

Active comparator
Normal saline
30 patients will receive placebo of 100ml 0.9% Nacl over 20 minutes followed by continuous infusion of Nacl for 72 hours.
Active comparator
methylene blue low dose
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.
Active comparator
methylene blue high dose
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Discontinuation of vasopressor
Time frame · 7 days
Registry description
Time for noradrenaline discontinuation

Secondary outcomes(1)

Mortality
Time frame · 28 days
Registry description
Number of deaths

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2025

Comparative study between high and low dose methylene blue infusion in septic cancer patients: a randomized, blinded, controlled study.

Shaker et al. 2025BMC anesthesiologycited by 11

PMID 39780053PMC11707904DOI 10.1186/s12871-024-02792-3PUB-39780053

CC BY

Download PDF

Indexing hint: Case report · 2022

Methylene Blue in Refractory Shock.

Chalise et al. 2022Cureus

PMID 36505110PMC9728991DOI 10.7759/cureus.31158PUB-36505110

CC BY

Download PDF

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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