Health Condition 1: A418- Other specified sepsis
Conditions
Interventions
Intervention1: Norepinephrine: started at 0.1 mcg/kg/min, increase to 0.2 mcg/kg/min after 15 min if shock persists, increase to 0.3 mcg/kg/min after next 15 min if shock persists, increase to 0.4 mcg
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Neonates are eligible if they have sepsis and shock. The sepsis will be defined as either culture-proven sepsis or probable sepsis. The Shock will be defined by presence of either one or both of criteria A or B in a neonate who either has received intravenous fluid resuscitation of 10 to 20 mL per kg over 30 to 60 min or does not require intravenous fluid resuscitation as per beside Neonatologist. Criterion A- systolic blood pressure less than 5th percentile for post-conceptional age as per Zubrows charts. Criterion B- Presence of any two or more of following six parameters- HR more than 205 per min, Central pulses either weak OR bounding, capillary filling time more than 3 sec OR flash refill, Skin mottled or cool OR flushed, Urine output less than 0.5 mL per kg per hr in the preceding 6 hours, Diastolic blood pressure less than 5th percentile for post-conceptional age as per Zubrows charts
Exclusion criteria
Exclusion criteria: Major malformations; gestation below 25 weeks; differences in sex development; congenital heart diseases except PFO, VSD, PDA; congenital heart block; post-surgical neonates; previous enrolment for past episode of shock; outborn neonates with inadequate clinical details; and shock due to other etiologies such as Moderate to severe hypoxic-ischemic encephalopathy as defined by Levene classification for neonates equal to or below 35 weeks or stage 2 to 3 HIE as per modified Sarnat staging for neonates above 35 weeks, transitional circulatory dysfunction defined as cardiovascular dysfunction in the first 12 hours of life in extremely low birth weight neonates who are born without any overt maternal risk factor of infection, volume loss such as antepartum hemorrhage, urine output more than 4 mL/kg/day, presence of 3 or more watery stools, overt blood loss, or weight loss of more than 10% in previous 48 hours, clinical signs of dehydration, tension pneumothorax or pneumopericardium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all-cause mortality i.e. death due to any cause within 28 days of onset of septic shockTimepoint: Death occurring within 28 days after the onset of septic shock | — |
Secondary
| Measure | Time frame |
|---|---|
| Vasoactive inotrope scoreTimepoint: Total VIS on D1, Average VIS on D1, Maximum VIS and cumulative VIS over the entire duration of vasoactive agents;Duration of vasoactive drugsTimepoint: Time between start of vasoactive drug till the last vasoactive drug is tapered off;Change in physiological (HR, SBP, DBP, MAP)Timepoint: over the duration of vasoactive drugs;Lactate clearanceTimepoint: in first 6-24 hours therapy;Failure of shock reversalTimepoint: with maximum dose of study drug;Sepsis related organ dysfunctionTimepoint: over the duration of vasoactive drug use;Medium term complications BPD, ROP, NEC, PVLTimepoint: Till discharge from hospital | — |
Countries
India
Contacts
Public ContactShiv Sajan Saini
Post Graduate Institute of Medical Education and Research
Outcome results
None listed