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A randomized trial to study the utility of Early placement of Central Venous Catheter in children with septic shock.

Utility of Early Central Venous Catheter Placement in Management of Septic Shock in Pediatric Emergency Room: A Randomized Controlled Trial. - eCVC Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046879
Enrollment
170
Registered
2022-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: 2- Placement

Interventions

Intervention1: Early central venous catheter: The enrolled children will be subjected to internal jugular or subclavian venous catheterization within 1 hour of labelling fluid refractory septic shock

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children 3 months to 12 years of age with fluid refractory septic shock (after 20-40 ml/kg crystalloid over 1 hour)

Exclusion criteria

Exclusion criteria: Contraindications for central venous catheterization Post cardiac arrest or ongoing cardiopulmonary resuscitation Primary cardiac disease Severe acute malnutrition Chronic kidney disease Chronic liver disease Already received fluid boluses and/or vasoactive drugs in referring hospital or prior to enrolment. Requirement for surgery within 6 hours of diagnosis Refused consent by the parents/guardians

Design outcomes

Primary

MeasureTime frame
Shock resolution at 6 hours after CVC placementTimepoint: 6 hours after CVC placement

Secondary

MeasureTime frame
1. Shock resolution at 2 hours of CVC placement. 2. Shock resolution at 4 hours of CVC placement. 3. Time (in hours) to achieve the therapeutic endpoints of shock resuscitation. 4. Pediatric Logistic Organ Dysfunction (PELOD) score 5. Fluid boluses needed in first 6 hours 6. Vasoactive inotrope score (VIS) 7. Need and duration of mechanical ventilation 8. Need for blood products 9. Number of dysfunctional organs 10. Rate of CLABSI 11. Duration of PICU stay 12. Duration of hospital stay 13. In-hospital mortality 14. Protocol compliance 15. Incidence of CVC related complications Timepoint: Till discharge or death

Countries

India

Contacts

Public ContactSuresh Kumar

PGIMER, Chandigarh

sureshangurana@gmail.com9855373969

Outcome results

None listed

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