Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486174
Status:
WITHDRAWN
Last Update Posted:
2008-05-29
First Post:
2007-06-12
Brief Title:
Methylene Blue in Sepsis A Randomized Controlled Trial
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Intermittent Bolus Infusion of Methylene Blue to Reduce Norepinephrine Requirements in Sepsis A Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
primary site withdrew due to competing study never enrolled any subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMURF
Brief Summary:
The purpose of this study is to investigate whether the addition of Methylene Blue to the standard treatment of septic shock will reduce vasopressor requirements
Detailed Description:
The management of severe infections sepsis and septic shock is a serious problem facing physicians Septic shock kills 10000 Canadians every year It is the most common cause of death in intensive units and the rates of sepsis and septic shock continue to increase annually
Septic shock is a complex interaction between pathologic vasodilation relative and absolute hypovolemia myocardial depression and altered microvascular function resulting from a systemic inflammatory response to infection After restoration of the circulating volume many patients continue to suffer from a maldistribution of blood flow Current hypotheses suggest that global indicators of hypoperfusion serum lactate hypotension decreased oxygen delivery represent an averaging of areas of normal or increased blood flow with areas where blood flow is decreased These under-perfused areas become more hypoxic The resulting tissue damage leads to more inflammation and more maldistribution perpetuating a vicious cycle progressing on to death
Vasopressive agents are used in an attempt to maintain mean arterial blood pressure and restore perfusion but these agents work globally potentially worsening blood flow to the under-perfused areas As well many vasopressors have deleterious side effects such as metabolic and endocrine functions and changes to regional blood flow
The microvascular changes are mediated by primarily nitric oxide NO Baseline levels of nitric oxide are produced by constitutive Nitric Oxide Synthase cNOS with NO levels measured in the nano-molar range Inflammatory mediators cause increased production of inducible Nitric Oxide Synthase iNOS leading to NO levels measured in the micro-molar range
Suppression of nitric oxide production using non-specific NOS inhibitors has had discouraging results Methylene Blue is a selective iNOS inhibitor The purpose of this pilot study is to confirm safety and demonstrate signs of benefit in the use of methylene blue in sepsis In particular this study will examine whether the addition of methylene blue to standard early goal directed therapy in sepsis will reduce vasopressor requirements
Septic shock is a complex interaction between pathologic vasodilation relative and absolute hypovolemia myocardial depression and altered microvascular function resulting from a systemic inflammatory response to infection After restoration of the circulating volume many patients continue to suffer from a maldistribution of blood flow Current hypotheses suggest that global indicators of hypoperfusion serum lactate hypotension decreased oxygen delivery represent an averaging of areas of normal or increased blood flow with areas where blood flow is decreased These under-perfused areas become more hypoxic The resulting tissue damage leads to more inflammation and more maldistribution perpetuating a vicious cycle progressing on to death
Vasopressive agents are used in an attempt to maintain mean arterial blood pressure and restore perfusion but these agents work globally potentially worsening blood flow to the under-perfused areas As well many vasopressors have deleterious side effects such as metabolic and endocrine functions and changes to regional blood flow
The microvascular changes are mediated by primarily nitric oxide NO Baseline levels of nitric oxide are produced by constitutive Nitric Oxide Synthase cNOS with NO levels measured in the nano-molar range Inflammatory mediators cause increased production of inducible Nitric Oxide Synthase iNOS leading to NO levels measured in the micro-molar range
Suppression of nitric oxide production using non-specific NOS inhibitors has had discouraging results Methylene Blue is a selective iNOS inhibitor The purpose of this pilot study is to confirm safety and demonstrate signs of benefit in the use of methylene blue in sepsis In particular this study will examine whether the addition of methylene blue to standard early goal directed therapy in sepsis will reduce vasopressor requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PSI Grant application 2006-36 | None | None | None |