Health Condition 1: P299- Cardiovascular disorder originating in the perinatal period, unspecified
Conditions
Interventions
Intervention1: Norepinephrine: dose 0.06 mg/kg norepinephrine will be diluted in 10 ml NS and infusion will be initiated @ 1 ml/hr (0.1 microgram/kg/min) and will be increased to 2ml/per hour (0.2mcg/
Sponsors
Non funded
Eligibility
Inclusion criteria
Inclusion criteria: 1 Infants more than or equal to 34 weeks gestational age and more than or equal to 72 hours of life upto 3 months of age with fluid refractory shock will be enrolled in the study after taking informed consent from one of the parents.
Exclusion criteria
Exclusion criteria: 1 Potentially lethal congenital malformations 2 Obvious blood loss 3 Post cardiac arrest shock. 4 Clinically suspected or echo proven congenital heart disease 5 Moderate to severe hypoxic ischaemic encephalopathy 6 Vasopressor drugs started prior to enrolment 7 Fluid responsive shock 8 Decline to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal of shock during first one hour of vasoactive drug infusion Reversal of shock will be considered if SBP as well as DBP lesser than fifth centile & CFT more than 3 sTimepoint: 1 hr post initiation of drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Time taken for reversal of shock Vasoactive inotropic score at six hour twelve hours twenty hours forty eight hours seventy hours Median time of complete shock resolution Lactate level as a marker of microcirculation from baseline to 6 hour All-cause mortality by 28 days of life Incidence of complications like arrythmia lactic acidosis skin necrosis intestinal gangrene Total duration of hospital stay. Timepoint: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 6 hours, 24 hours & 48 hours | — |
Countries
India
Contacts
Public ContactDr Kirti M Naranje
Sanjay Gandhi Postgradute Institute of Medical Sciences,
Outcome results
None listed