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Comparative study of a low sodium fluid to that of a high sodium fluid when given as maintenance fluid in hospitalised children.

Open label randomised controlled trial of half normal saline(0.45%) versus normal saline(0.9%) as intravenous maintenance fluids in hospitalised children.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018350
Enrollment
240
Registered
2019-04-01
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: R638- Other symptoms and signs concerning food and fluid intake

Interventions

Intervention1: Half Normal Saline(0.45%): Half Normal Saline (0.45% saline) as calculated by Holliday Segar Formula Control Intervention1: Normal Saline(0.9%).: Normal Saline (0.9% saline) as calculat

Sponsors

Director LHMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children in the age group of 1-18 years admitted in Kalawati Saran Children Hospital ,New Delhi. 2. Receiving intravenous fluid within 24 hrs of admission.

Exclusion criteria

Exclusion criteria: 1. Patients who have already received some intravenous fluid at the time of admission. 2.Patients with any neurological complaints eg. seizures, altered sensorium, lethargy, meningitis etc.; acute kidney injury; chronic kidney disease ; severe acute malnutrition; dehydrated or in shock patients ; those having ongoing blood loss or gastrointestinal losses; those receiving ORS

Design outcomes

Primary

MeasureTime frame
Primary outcome variable: Proportion of children developing hyponatremia (serum sodium 135meq/L) at 0 and 24hr of receiving intravenous maintenance fluids . Timepoint: at 0 hours and at 24 hours of administering fluid therapy

Secondary

MeasureTime frame
1. Mean serum sodium levels. 2. Percentage of patients who develop symptomatic hyponatremia ie. seizures (not attributable to other cause). 3. The urine and blood osmolality at 0 and 24 hours. 4. The blood urea and serum creatinine levels Timepoint: at 0 hours and at 24 hours of administering fluid therapy

Countries

India

Contacts

Public ContactDr Harish K Pemde

LHMC New Delhi

harishpemde@gmail.com9868549681

Outcome results

None listed

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