To compare between two cardiac medication that is epinephrine and norepinephrine in terms of efficacy in the children with shock due to infective origi

Not Applicable

Conditions: Health Condition 1: I958- Other hypotension

Registration Number: CTRI/2022/05/042627

Lead Sponsor: Apollo Hospital Chennai

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

All children aged 1 month to 17 years with early septic shock- suspect or confirmed sepsis and unresolved shock/hypoperfusion after initial 10-20ml/kg of fluid bolus

Exclusion Criteria

1.Children with fulminant myocarditis

2.Children with unrepaired congenital heart disease

3.Post-operative sepsis/septic shock within 48 hours of bypass surgery.

4.Children with Severe Acute Malnutrition

5.Children with chronic kidney disease.

6.Parents not willing to participate in the study

7.Caregiver/Physician unwilling for patient to be enrolled

8.Post-arrest shock and cardiac dysfunction

9.Moribund patients in whom anticipated survival < 24 hrs (since many are in are in recalcitrant downward spiral of overall condition where the impact of one or other vasoactive may be difficult to assess).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficacy of norepinephrine versus epinephrine as the first-line vasoactive therapy with respect to resolution of shock in children aged 2 months to 17 years with early septic shock.Timepoint: AT 6 AND 12 HOURS OF STARTING OF THE STUDY DRUG

Secondary Outcome Measures

Name	Time	Method
<br/ ><br>1.Median time for shock resolution <br/ ><br>2.Fluid requirement in 0-6 hours and 6-24 hours <br/ ><br>3.Vasoactive-inotrope score at 6, 12, 24, 48 and 72 hours <br/ ><br>4.7-day vasopressor-free hours <br/ ><br>5.7-day ventilator-free hours <br/ ><br>6. 14-day PICU free days <br/ ><br>7.Early (within 7 days) and late (7-28 day) mortality in both groups <br/ ><br>8.Proportion of patients in each group who fulfilled â??Stopping Criteriaâ?? <br/ ><br>9.Occurrence of adverse events i.e. tachycardia, tachyarrhythmia and lactic acidosis, skin necrosis, gangrene. Lactate trends (baseline and 6 hr) <br/ ><br>10.PELOD-2 score at 0, 24, 48 and 72 hours. <br/ ><br>11.Renal replacement requirements <br/ ><br>Timepoint: TILL DISCHARGE