Status:
COMPLETED
Methylene Blue in Early Septic Shock
Lead Sponsor:
Hospital Civil de Guadalajara
Conditions:
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Septic shock is a subset of sepsis characterized by a decrease in vascular tone, which contributes to impaired regional blood flow distribution, and leads to organic failure. Besides intravenous fluid...
Detailed Description
Unlike sepsis, septic shock mortality is not declining for the last decade, and is still around 40%. After restoring intravascular volume, many patients need vasopressor agents to maintain arterial bl...
Eligibility Criteria
Inclusion
- Septic shock diagnosis, according to the Sepsis-3 consensus.
- Prior adequate fluid resuscitation according to dynamic predictors of volume responsiveness.
- More than 6 h and less than 24 h of norepinephrine requirement to maintain a mean arterial pressure ≥65 mmHg.
Exclusion
- Age \< 18 years.
- Pregnancy.
- Not expected to survive 48 hours.
- Presence or high suspicion of concurrent hemorrhagic, obstructive or hypovolemic shock.
- Personal or familiar history of glucose-6-phosphate dehydrogenase deficiency.
- Allergic to methylene blue, phenothiazines, or food dyes.
- Recent intake (4-weeks) of selective serotonin re-uptake inhibitors.
- Refusal of the patient or decision maker to enroll in the study.
Key Trial Info
Start Date :
March 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04446871
Start Date
March 17 2017
End Date
January 25 2021
Last Update
November 4 2022
Active Locations (1)
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1
Hospital Civil Fray Antonio Alcalde
Guadalajara, Mexico, 44280