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Comparison of two different fluid volumes for the initial treatment of infection associated inadequate blood circulation in children

10ml/kg vs 20ml/kg fluid bolus for initial resuscitation of septic shock in children presenting to emergency department: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041446
Enrollment
120
Registered
2022-03-29
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: R57- Shock, not elsewhere classified

Interventions

Intervention1: 10 ml/kg of 0.9% saline: Fluid bolus volume of 10ml/kg of 0.9% saline administered during fluid resuscitation over 10-20 minutes Control Intervention1: 20 ml/kg of 0.9% saline: Fluid bo

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children presenting to the emergency department with septic shock. septic shock is defined as: Suspected or confirmed infection with SIRS and one or more of the following: Capillary refill time of 3 or more seconds, weak radial-pulse volume, other signs of poor perfusion as per treating clinician, hypotension

Exclusion criteria

Exclusion criteria: 1. Cardiopulmonary resuscitation 2. Severe anemia with congestive cardiac failure 3. Transfer from another hospital with prior fluid resuscitation 4. Known congenital heart disease 5. Raised intracranial pressure

Design outcomes

Primary

MeasureTime frame
Need for invasive ventilation and/or 25% worsening in oxygenation parametersTimepoint: At 6 hours

Secondary

MeasureTime frame
Duration of resolution of shockTimepoint: At any point during hospital stay;Fluid overload% (FO%)Timepoint: at 24 hours, 48 hours and 72 hours;In hospital mortalityTimepoint: At any point during hospital stay;Resolution of shockTimepoint: At 6 hours

Countries

India

Contacts

Public ContactJayashree Muralidharan

PGIMER

mjshree@hotmail.com

Outcome results

None listed

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