Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: Methylene Blue: Subjects in the intervention arm will receive a 1 mg/kg bolus of Methylene blue intravenously over 30 minutes, followed by an intravenous infusion of methylene blue (0.1
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: subjects must fulfill all the following: 1.Definite/probable sepsis: Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein >10 mg/dL; (b) procalcitonin as per age-appropriate cut-off(c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d)chest X-ray adjudged as pneumonia by two independent Neonatologists. 2. Shock: adapted from the definition given by Davis et al (a) Either SBP (b) Presence of any 2 of the following 6 parameters i. HR >205/min ii. Central pulses either week OR bounding iii. CRT >3 sec OR flash refill ( iv. skin mottled/cool OR flushed v. urine output vi. DBP 3. Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml/kg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg/kg/min) or epinephrine (maximum dose 0.4 µg/kg/min) or norepinephrine (maximum dose 0.4 µg/kg/min).
Exclusion criteria
Exclusion criteria: Excluded if =1 criteria positive 1.G6PD deficient or family history of G6PD deficiency 2.potentially lethal malformation 3.congenital heart disease 4.severe acute kidney injury (stage II or III as per the modified KDIGO score) 5.family history of allergy to methylene blue or food dyes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality Timepoint: Within 7 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospital stayTimepoint: Total duration of hospital stay post randomization;Mortality during hospital stayTimepoint: During hospital stay;Septic shock-related mortalityTimepoint: within 7 days after randomization;Serious adverse effects, with special reference to oliguria, gastrointestinal bleeds, abdominal distension, and bluish discoloration of skin and urine.Timepoint: During hospital stay;The following echocardiographic parameters will be measured: 1.fractional shortening 2.left ventricular end-diastolic diameter (LVEDD) 3.left ventricular end-systolic diameter (LVESD) 4.Aortic diameter 5.velocity time integral (LVI)Timepoint: 24 and 48 hours post randomization;Time taken for all inotrope and vasopressor therapy to finally stopTimepoint: Within 7 days after randomization;Time taken to achieve therapeutic and 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.Timepoint: 7 days;Time taken to stop inotrope/vasopressor treatmentTimepoint: During hospital stay | — |
Countries
India
Contacts
Public ContactSourabh Dutta
Post Graduate Institute of Medical Edication, Chandigarh
Outcome results
None listed