a clinical trial to find the most appropriate maintenance fluid in children with central nervous system infection

A randomized controlled trial of intravenous maintenance fluids ( isotonic vs hypotonic) in children with central nervous system infections.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002637

Enrollment

Registered

2012-05-09

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- to compare the incidence of hyponatremia with maintenance fluids ( isotonic and hypotonic) in children with CNS infections

Interventions

Intervention1: Maintenance fluid: Three arm subjects will receive oneo f the three types of maintenance fluid according to Holliday Segar formula for 24 hours Control Intervention1: maintenance fluids

Eligibility

Inclusion criteria

Inclusion criteria: children of age 2month to 5 years with a clinical diagonosis of CNS infections requiring maintenance fluids for atleast 24 hrs

Exclusion criteria

Exclusion criteria: -serum sodium less than 135 or more than 145 mmol/ L before starting maintenance fluids - previously diagonosed renal disease -documented cerebral salt wasting -hepatic failure with fluid retention -shock at presentation -diarrhoea -known endocrinal disorder(DI/IDDM/CAH) -severe malnutrition(asTBW in malnourished children is 70-80%as compared to 60% age matched well nourished controls) -DKA/cranioenchephalic trauma (at risk of cerebral edema)

Design outcomes

Primary

Measure	Time frame
Proportion of patients developing hyponatremia(serum sodium 135mmol/L) after receiving intravenous maintenance fluids for atleast 24 hours.Timepoint: 24hrs	—

Secondary

Measure	Time frame
1. serum sodium values at 6,12,18,24 hours of receiving maintenance fluids Timepoint: 0,6,12,18,24 hrs;prism III scoreTimepoint: 0 and 24 hrs	—

Countries

India

Contacts

Public ContactDr Harish K Pemde

Professor - Pediatrics LHMC, New Delhi

harishpemde@gmail.com09868549681

Outcome results

None listed

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