orepinephrine versus dopamine for septic shock in neonates

Not Applicable

Completed

Conditions: Health Condition 1: P298- Other cardiovascular disorders originating in the perinatal period

Registration Number: CTRI/2023/02/049357

Lead Sponsor: All India Institute of Medical Sciences, Rishikesh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

All neonates (term and preterm) with fluid refractory septic shock admitted in the NICU will be included. Terms neonates will be included until day 28 of life. Preterm neonates will be included till 40 weeks post menstrual age.

Exclusion Criteria

Major congenital anomaly

Moderate to severe HIE till first 72 hours of life

Diagnosed congenital heart disease

Already on inotropes

Post-operative patients developing shock in the first 24 hours of surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of shock reversal. Shock reversal shall be defined as presence of both: <br/ ><br>1. Correction of hypotension: SBP, DBP and MAP more than third centile <br/ ><br>2. Clinical end-points (any two): <br/ ><br>a) Capillary refill less than or equal to 2 seconds <br/ ><br>b) Normal pulses with no difference in quality between peripheral and central pulses <br/ ><br>c) Warm extremitiesTimepoint: During hospital stay

Secondary Outcome Measures

Name	Time	Method
•Change in cerebral tissue oxygen saturation (crSO2) at 30-60 minutes and 6 hours after initiation vasopressor support <br/ ><br>•Need for further escalation of vasoactive drugs for a period of = 120 min thereafter <br/ ><br>•Time to reversal of shock <br/ ><br>•Requirement of additional vasoactive drugs/ hydrocortisone <br/ ><br>•Lactate clearance at 6-8 hours and 24 hours after initiation of vasopressor support <br/ ><br>•Incidences of hyperglycemia, tachyarrhythmia and sinus tachycardia =200/min <br/ ><br>•Need and duration of respiratory support <br/ ><br>•Change in the following acid base parameters at baseline and at 24 hours after diagnosis of shock: pH, bicarbonate, base excess, lactate <br/ ><br>•Incidence of morbidities, i.e., Intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) stage II/III and retinopathy of prematurity (ROP) any stage until hospital discharge <br/ ><br>•Final outcome <br/ ><br>Timepoint: During hospital stay