Methylene Blue in Early Septic Shock

• Status: Completed
• Trial end date: 2021-01-25
• Target enrollment: 0
• Participant gender: All

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 fluids and adequate antimicrobial therapy, patients with septic shock require vasopressor support, which can lead to many adverse effects, therefore, non-vasopressor agents that can improve hemodynamic status are needed. In this randomized controlled-study, the investigators will address the efficacy and safety of infusion with methylene blue in patients with septic shock.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Civil de Guadalajara
• Treatments: Methylene Blue

Criteria

Inclusion Criteria:

• Septic shock diagnosis, according to 2016 Surviving Sepsis Campaign Guidelines.

• 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 Criteria:

• 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.