Methylene Blue in Early Septic Shock

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Hospital Civil de Guadalajara
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Updated on 5 August 2020
See if I qualify
shock
resuscitation
antibiotics
antibiotic therapy
norepinephrine
sepsis
methylene blue
0.9% sodium chloride
vasoconstrictor
septic shock
administration of intravenous fluids
sodium chloride

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.

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 blood pressure, which leads to improvement of perfusion at some vascular beds, however some organs may suffer from maldistribution of blood flow. These changes of regional blood flow may compromise oxygen delivery and perpetuate the inflammation and tissue damage associated with the state of shock.

One of the main mechanisms of vasodilation after inflammatory insults, is the activation of the inducible isoform of Nitric Oxide Synthase (iNOS), and the subsequent increase in the levels of nitric oxide, which even reduces the response to vasoconstrictor agents. Methylene blue (MB) is a selective inhibitor of iNOS, which has been used successfully in patients with post-cardiopulmonary bypass associated vasoplegia, however, the evidence of the use of MB in septic shock patients is limited to case reports, observational and small studies. In this randomized controlled trial, the investigators will compare the efficacy and safety outcomes of repeated doses of MB in patients with septic shock.

Details
Condition Toxic Shock Syndrome
Age 18years - 80years
Treatment Methylene Blue, 0.9% sodium chloride
Clinical Study IdentifierNCT04446871
SponsorHospital Civil de Guadalajara
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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shock
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administration of intravenous fluids
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