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Effect of early versus delayed initiation of inotropes after fluid boluses in Pediatric septic shock

A Randomized Controlled Trial to Study the Effect of initiation of Inotropes after First, Second and Third boluses of Normal Saline in Children with Septic Shock - INOTROPE-SEPSIS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110660
Enrollment
120
Registered
2026-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: N1 Group: Inotropes initiated after completion of first normal saline bolus of 20 ml per kg in children with septic shock Control Intervention1: N2 Group: Inotropes initiated after comp

Sponsors

Gajra Raja Medical College Gwalior
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 year to 14 years diagnosed with septic shock receiving fluid resuscitation boluses along with vasoactive drugs. Patients who have not received prior fluid correction or vasoactive drugs

Exclusion criteria

Exclusion criteria: childrens aged 1 year or more than 14 years. patients who received prior intravenous fluid boluses. patients with severe acute malnutritions, severe anemia, diabetic ketoacidosis and congestive cardiac failure.

Design outcomes

Primary

MeasureTime frame
Reduction in mortality among children with septic shock receiving inotropes after first, second and third fluid bolusesTimepoint: During hospital stay or up to discharge or death.

Secondary

MeasureTime frame
Time taken to achieve shock resolutionTimepoint: within first 24 hours of management;Total amount of fluid received during first 24 hours of managementTimepoint: First 24 hours of admission;Complications related to fluid overload & vasoactive medicationsTimepoint: During hospital stay;Duration of vasoactive medication requirment.Timepoint: During PICU stay

Countries

India

Contacts

Public ContactDr Ayush Pakhale

Gajra Raja Medical College, Gwalior

ayushpakhale21@gmail.com83305807331

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026