Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04446871
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2020-06-22
Brief Title:
Methylene Blue in Early Septic Shock
Sponsor:
Hospital Civil de Guadalajara
Organization:
Hospital Civil de Guadalajara
Study Overview
Official Title:
Early Use of Methylene Blue in Patients With Septic Shock a Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHOCKEM-Blue
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 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None