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Comparison of two drugs in improvement of shock in children with severe sepsis

Comparison of efficacy of epinephrine versus norepinephrine as a first line vasoactive agent in resolution of septic shock in children : A single centered, double blinded randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045022
Enrollment
120
Registered
2022-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: - Health Condition 2: I998- Other disorder of circulatory system

Interventions

Intervention1: Adding vaso active agents: Norepinephrine Control Intervention1: Epinephrine: 0.1mg/kg ,intravenously,15 mins , can be titration upto 0.3mg/kg every 15 mins Control Intervention2: Addin

Sponsors

Dr JANARTHANAN A
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the patients admitting in Paediatric emergency and pediatric intensive care unit ,AIIMS Patna , having signs and symptoms at presentation suggestive of septic shock as defined above & patients admitted in pediatric ward, later developing signs and symptoms of septic shock as per inclusion criteria. Age minimum : 1 month Age maximum : 15 years

Exclusion criteria

Exclusion criteria: Exclusion criteria : 1. Patients requiring CPR at presentation. 2. Patients with fluid responsive shock not requiring any vasoactive agent. 3. Patients with known cardiac disease requiring any specific vasoactive agent such as dobutamine and milrinone.

Design outcomes

Primary

MeasureTime frame
Resolution of shock is defined as a.Normalisation of heart rate (age and sex adjusted). b.Capillary refilling time less than 3 secs. c.Systolic and diastolic pressure above 5th percentiles. d.Improving urine output (more than 0.5 – 1 ml/kg/hr). Improving blood lactate levels (if initial levels elevated).Timepoint: at 15 mins,30 mins ,45 mins

Secondary

MeasureTime frame
To compare time taken for resolution of septic shock between two groups. To compare 28 days survival outcome between two groups.Timepoint: 30 mins vs 60 mins

Countries

India

Contacts

Public ContactJANARTHANAN A

AIIMS PATNA

lokeshdoc@yahoo.com9631638095

Outcome results

None listed

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