Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306001
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-20
Brief Title:
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
Post Graduate Institute of Medical Education and Research Chandigarh
Study Overview
Official Title:
Intravenous Methylene Blue for Treating Fluid-refractory Catecholamine-resistant Neonatal Septic Shock a Randomized Placebo-controlled Superiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Preterm infants born at less than 37 weeks of pregnancy sometimes develop a serious blood infection leading to low blood pressure which does not respond to saline or to the standard medicines for increasing blood pressure such as dopamine and epinephrine The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue MB versus not giving MB to such preterm infants who are unresponsive to standard treatment The main questions that this study aims to answer is
1 Whether MB treatment reduces death to any cause as compared to no MB treatment
2 Whether treatment with MB reduces the time to achieve normal blood pressure
3 Whether treatment with MB reduces the time to stoppage of all blood pressure medications steroids and normal saline
4 Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours
1 Whether MB treatment reduces death to any cause as compared to no MB treatment
2 Whether treatment with MB reduces the time to achieve normal blood pressure
3 Whether treatment with MB reduces the time to stoppage of all blood pressure medications steroids and normal saline
4 Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours
Detailed Description:
Preterm infants with definite or probable sepsis and fluid-refractory catecholamine-resistant septic shock will be eligible for enrolment if they have no contraindication to receive MB After obtaining parental consent they will be stratified as per the first-line catecholamine used and randomly allocated to receive MB bolus followed by infusion or no MB for 24 hours They will be observed for all-cause mortality primary outcome cause-specific mortality time to achieve hemodynamic stability and adverse effects secondary outcomes over a 7-day period all-cause mortality and cause-specific mortality hospital stay and duration of hospital stay
The main questions it aims to answer are
1 To determine whether treatment with intravenous MB therapy reduces all-cause mortality when compared to no MB treatment among preterm neonates with catecholamine-resistant septic shock
2 To compare the time to achieve therapeutic endpoints among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
3 To compare time to stoppage of all inotropevasopressor treatment among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
4 To compare echocardiographic parameters at 24 hours after randomization among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
The main questions it aims to answer are
1 To determine whether treatment with intravenous MB therapy reduces all-cause mortality when compared to no MB treatment among preterm neonates with catecholamine-resistant septic shock
2 To compare the time to achieve therapeutic endpoints among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
3 To compare time to stoppage of all inotropevasopressor treatment among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
4 To compare echocardiographic parameters at 24 hours after randomization among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
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