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Maintenance intravenous fluid in children

Isotonic versus hypotonic maintenance intravenous fluid therapy in hospitalized children: an open label randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009639
Enrollment
170
Registered
2017-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- admitted patients requiring maintenance intravenous fluid.

Interventions

Intervention1: isotonic fluid: isotonic (0.9% normal saline in 5% dextrose) maintainance fluid Control Intervention1: hypotonic fluid: 0.45% normal saline in 5% dextrose intravenous fluid in normal ma

Sponsors

Chacha Nehru Bal Chikitsalaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All hospitalized children between 3 months to 5 years requiring intravenous maintenance fluid for at least 24 hours.

Exclusion criteria

Exclusion criteria: 1.Children with renal, hepatic or congestive heart failure 2.Children with hyponatremia (Na 145) at admission 3.Children with dehydration 4.Children requiring fluid boluses 5.Children who have received diuretics within last seven days 6.Children with severe malnutrition 7.Children with hemodynamic instability and requiring inotropes with or without mechanical ventilation 8.Children who had received intravenous fluid therapy in last 24 hours prior to admission

Design outcomes

Primary

MeasureTime frame
Incidence of hyponatremia (serum Na 135 meq/L) in children receiving isotonic fluid (0.9% normal saline with 5% dextrose) in comparison to children receiving hypotonic fluid (0.45% normal saline with 5% dextrose)Timepoint: 0 hour 12 hours 24 hours

Secondary

MeasureTime frame
Incidence of moderate (Na130 meq/L), severe (Na125 meq/L) and symptomatic hyponatremia (lethargy, altered sensorium or seizure) Change in serum sodium level from baseline Incidence of hypernatremia (serum Na 145 meq/L) Timepoint: 0 hour 12 hours 24 hours

Countries

India

Contacts

Public ContactDr Kaustuv Mitra

Chacha Nehru Bal Chikitsalaya

manishkp75@yahoo.com9643308216

Outcome results

None listed

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