A Phase 2/3 interventional study of Methylene Blue and Placebo in Neonatal Sepsis and Shock, Septic, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Not yet recruiting at 1 site in India. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2/3, Interventional, and Treatment
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:
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
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Screening Criteria: preterm infants (\<37 weeks, \<28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following
Shock: adapted from the definition given by Davis et al 2017
Exclusion Criteria:
excluded if ≥1 criterion positive:
Subjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h.
Drug: Methylene Blue
Subjects in the control arm will receive a placebo infusion (normal saline) at the same volumetric rate.
Other: Placebo
Subjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h.
Also known as: MB
Subjects in the placebo arm will receive normal saline in the same volumetric dose as methylene blue in the intervention arm
Also known as: Normal saline
All-cause mortality within 7 days after randomization
Mortality due to any cause over 7 days after randomization
Time frame: 7 days
Time taken to achieve therapeutic end-points within 7 days after randomization
Time taken to achieve therapeutic end points of shock (which include capillary refill time less than 3 seconds, normal volume pulses, warm extremities, urine output greater than 1 ml/kg/h, normal sensorium, normal mean blood pressure, normal systolic blood pressure and normal diastolic blood pressure) up to 7 days after randomization.
Time frame: 7 days
Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation
Time taken for all inotrope and vasopressor therapy to finally stop up to a maximum of 7 days after randomisation
Time frame: 7 days
Echocardiographic fractional shortening at 24 hour after randomization
Fractional shortening will be calculated on echocardiography by measuring the percentage change in the left ventricular diameter during systole at 24 hours after randomization.
Time frame: 24 hour
Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization
Left ventricular end-diastolic diameter (LVEDD) will be measured in millimetres by echocardiography at 24 hour after randomization
Time frame: 24 hour
Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization
Left ventricular end-systolic diameter (LVESD) will be measured in millimeters by echocardiography at 24 hour after randomization
Time frame: 24 hour
Aortic diameter by echocardiography at 24 hour after randomization
Aortic diameter will be measured in millimeters by echocardiography at 24 hour after randomization
Time frame: 24 hour
Velocity time integral (LVI) by echocardiography at 24 hours after randomization
Velocity time integral (LVI) will be measured in centimeters by echocardiography at 24 hours after randomization to calculate the cardiac output.
Time frame: 24 hour
Echocardiographic fractional shortening at 48 hour after randomization
Fractional shortening will be calculated on echocardiography by measuring the percentage change in the left ventricular diameter during systole at 48 hours after randomization.
Time frame: 48 hour
Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization
Left ventricular end-diastolic diameter (LVEDD) will be measured in millimeters by echocardiography at 48 hour after randomization
Time frame: 48 hour
Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization
Left ventricular end-systolic diameter (LVESD) will be measured in millimeters by echocardiography at 48 hour after randomization
Time frame: 48 hour
Aortic diameter by echocardiography at 48 hour after randomization
Aortic diameter will be measured in millimeters by echocardiography at 48 hour after randomization
Time frame: 48 hour
Velocity time integral (LVI) by echocardiography at 48 hours after randomization
Velocity time integral (LVI) be measured by echocardiography in centimeters at 48 hours after randomization to calculate the cardiac output.
Time frame: 48 hour
Time taken to stop vasopressor treatment
Time taken to stop all vasopressors during hospital stay up to a maximum of 100 days
Time frame: 100 days
Mortality during hospital stay
Mortality during the period of hospital stay up to a maximum of 100 days
Time frame: 100 days
Serious adverse effects
Serious adverse effect with special reference to oliguria, gastrointestinal bleeds, abdominal distension, and bluish discoloration of skin and urine during hospital stay up to a maximum of 100 days
Time frame: 100 days
Septic shock-related mortality
Mortality attributed to septic shock up to 7 days post-randomisation
Time frame: 7 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized, individual patient data pertaining to publications from the study which are in the public domain will be shared with other researchers planning to conduct a study, upon reasonable written request
Supporting information: Study protocol, Sap, Icf
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh