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Comparison of serum sodium levels following intravenous administration of isotonic and hypotonic solutions in young children: a randomized controlled trial

Comparison of serum sodium levels following intravenous administration of isotonic and hypotonic solutions in young children: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201212004
Enrollment
140
Registered
2020-12-12
Start date
2020-11-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

changing of serum sodium after 24 hr intravenous fluid administration hypotonic solutions, isotonic solutions, hyponatremia, metabolic acidosis, children

Interventions

Arm 2 receive hypotonic solution ,Arm 1 receive isotonic solution
Experimental Drug,Experimental Drug

Sponsors

Navamindradhiraj University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 5 Years

Inclusion criteria

Inclusion criteria: 1. Patients from 3 months to 5 years of age who admitted and require maintenance intravenous fluid solution 2. Initial serum sodium 130-140 mEq/L

Exclusion criteria

Exclusion criteria: 1. Patients with neurological disorders 2. Patients with congenital heart or acquired heart disease 3. Patients with hepatic disease 4. Patients with cancer 5. Patients with renal dysfunction 6. Patients with adrenal insufficiency 7. Patients with diabetes insidious 8. Patients with voluminous watery diarrhea 9. Patients with shock 10. Patients who had history of electrolyte imbalance 11. Patients who receive medication affect serum sodium e.g. diuretic

Design outcomes

Primary

MeasureTime frame
To study change in serum Na following the administration of hypotonic versus isotonic IVFS at 24 hour 24 hours after administration intravenous fluid serum sodium

Secondary

MeasureTime frame
To study Incidence of hyponatremia and hypernatremia 24 hours after administration intravenous fluid serum sodium,To study incidence of metabolic acidosis 24 hours after administration intravenous fluid serum HCO3, pH,To study change in serum Na following the administration of hypotonic versus isotonic IVFS at 48 hou 48 hours after administration intravenous fluid serum sodium

Countries

Thailand

Contacts

Public ContactOrnatcha Sirimongkolchaiyakul

Navamindradhiraj University

ornatcha@nmu.ac.th66818587632

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026