Low Dose Versus High Dose Methylene Blue in Septic Patients

NCT06005558 | Completed Phase 2 DMC

• 1 other identifier: Methylene blue
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Discontinuation of vasopressor

  Time for noradrenaline discontinuation

  7 days

Secondary Outcomes (1)

• Mortality

  28 days

Study Arms (3)

Normal saline

ACTIVE COMPARATOR

30 patients will receive placebo of 100ml 0.9% Nacl over 20 minutes followed by continuous infusion of Nacl for 72 hours.

Drug: Methylene Blue low dose; Drug: Methylene Blue high dose

methylene blue low dose

ACTIVE COMPARATOR

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.

Drug: Normal saline; Drug: Methylene Blue high dose

methylene blue high dose

ACTIVE COMPARATOR

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.

Drug: Normal saline; Drug: Methylene Blue low dose

Interventions

Normal saline DRUG

100 ml 0.9% Nacl over 20 minutes, followed by continuous infusion of normal saline for 72 hours.

Also known as: Control

methylene blue high dose; methylene blue low dose

Methylene Blue low dose DRUG

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.

Also known as: Low dose

Normal saline; methylene blue high dose

Methylene Blue high dose DRUG

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.

Also known as: High dose

Normal saline; methylene blue low dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 12588, Egypt

Location

Related Publications (2)

• Chalise 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 RESULT

• Shaker 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 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Saline Solution; Methylene Blue; Contraceptives, Oral

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia, ICU and Pain management

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: August 1, 2023
• Primary Completion: April 29, 2024
• Study Completion: May 15, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)