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Fluid bolus therapy in children with septic shock

FLuid therapy in Pediatric Septic Shock (FLiPSS): Determining optimal volume of fluid boluses - FLiPSS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030320
Enrollment
674
Registered
2021-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Restricted volume group: 10 ml/kg group: In this group, children will be managed as per American College of Critical Care Medicine guidelines (2017) for management of septic shock. The

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children 2 month to 17 years of age with features of septic shock – defined as children who have a suspected infection manifested by hypothermia or hyperthermia and have at least two clinical signs of decreased perfusion with or without hypotension

Exclusion criteria

Exclusion criteria: Children receiving boluses before enrolment Children with chronic kidney disease. Children with fulminant myocarditis Children with dengue shock syndrome Children with malaria Children with severe anemia (Hb • Severe acute malnutrition (wt/ht • Post-arrest shock and cardiac dysfunction • Moribund patients in who anticipated survival is

Design outcomes

Primary

MeasureTime frame
Shock resolution at 6 hoursTimepoint: At 6 hours of resuscitation

Secondary

MeasureTime frame
Proportion having fluid overload in first 24 hours , 48 hours and 72 hoursTimepoint: Measured at 24 hours, 48 hours and 72 hours of resuscitation;Vasoactive inotrope scoreTimepoint: Measured at 24 48 and 72 hours;Ventilator free daysTimepoint: Measured at day 28 since enrollment;ICU free daysTimepoint: Measured at day 28 of enrollment;Organ dysfunction using pediatric Sequential Organ Failure Assessment(pSOFA)scoreTimepoint: Measured at 24, 48 and 72 hours

Countries

India

Contacts

Public ContactJhuma Sankar

AIIMS Delhi

jhumaji@gmail.com09818399864

Outcome results

None listed

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