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

EFFICACY OF EPINEPHRINE VERSUS NOR-EPINEPHRINE AS THE INITIAL VASOACTIVE AGENT IN PAEDIATRIC SEPTIC SHOCK- A RANDOMIZED CONTROLLED TRIAL,EPINESS STUDY - EPINESS TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042627
Enrollment
30
Registered
2022-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: EPINEPHRINE VERSUS NOREPINEPHRINE: TO CHECK THE EFFICACY OF EPINEPHRINE VERSUS NOREPINEPHRINE AS THE INITIAL VASOACTIVE AGENT IN PEDIATRIC SEPTIC SHOCK Intervention2: norepinephrine: St

Sponsors

Apollo Hospital Chennai
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Median time for shock resolution 2. Fluid requirement in 0-6 hours and 6-24 hours 3. Vasoactive-inotrope score at 6, 12, 24, 48 and 72 hours 4. 7-day vasopressor-free hours 5. 7-day ventilator-free hours 6. 14-day PICU free days 7. Early (within 7 days) and late (7-28 day) mortality in both groups 8. Proportion of patients in each group who fulfilled â??Stopping Criteriaâ?? 9. Occurrence of adverse events i.e. tachycardia, tachyarrhythmia and lactic acidosis, skin necrosis, gangrene. Lactate trends (baseline and 6 hr) 10. PELOD-2 score at 0, 24, 48 and 72 hours. 11. Renal replacement requirements Timepoint: TILL DISCHARGE—

Countries

India

Contacts

Public ContactDr Parth Dalal

Apollo Hospital, Chennai

rajiarali@gmail.com9884058200

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026