Status:
COMPLETED
Low Dose Versus High Dose Methylene Blue in Septic Patients
Lead Sponsor:
National Cancer Institute, Egypt
Conditions:
Septic Shock
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 pa...
Detailed Description
Exaggerated host response to infection, may result in sepsis, which is life-threatening organ dysfunction . Though considered the number one cause of in-hospital deaths , it can be treatable with earl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06005558
Start Date
August 1 2023
End Date
May 15 2024
Last Update
July 5 2024
Active Locations (1)
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1
National Cancer Institute
Cairo, Egypt, 12588