Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03120637
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2017-02-28
Brief Title:
Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue in Sepsis A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-01
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:
CRuMBS
Brief Summary:
Mortality rates associated septic shock remains unacceptably high around 20-50 with refractory hypotension in half of these patients Widespread vasodilatation involves the activation of the soluble intracellular enzyme guanylate cyclase GC by nitric oxide NO resulting in the production of cyclic guanosine monophosphate cGMP Initially discovered as an endothelium-derived relaxing factor in blood vessels NO is made by the enzyme nitric oxide synthase NOS It has been suggested that the inhibition of NO generation might be a treatment option for sepsis and septic shock Methylene blue MB is a dye that easily crosses cell membranes inhibits iNOS and is capable of inhibiting the GC enzyme in vascular smooth muscle cellsEarly use of MB can block the progressive decrease in systemic vascular resistance of patients unresponsive to noradrenaline and mitigate the need for prolonged vasoconstrictor use The investigators propose to study the effect of methylene blue on cirrhotic adults with sepsis with refractory vasoplegia unresponsive to maximum doses of noradrenaline and vasopressin
Detailed Description:
None
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