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Which intravenous fluid should be given for hospitalized patients?: A prospective randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75155444
Enrollment
100
Registered
2007-09-28
Start date
2005-06-15
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Hyponatraemia Nutritional, Metabolic, Endocrine Hyponatraemia

Interventions

The patients were randomized to one of the three study arms prospectively. Stratified block randomization was performed, with each one-week block featuring a different intravenous solution. Randomizat

Sponsors

Istanbul University, Faculty of Medicine (Turkey)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged between 3 months to 16 years old who received intravenous fluids

Exclusion criteria

Exclusion criteria: 1. Dehydration 2. Cerebral oedema 3. Nephrotic syndrome 4. Hepatorenal syndrome 5. Plasma sodium level below 135 mmol/L 6. Congestive heart failure 7. Renal failure 8. Inborn error of metabolism 9. Protein energy malnutrition 10. Patients receiving mannitol or diuretics 11. Patients whose fluid therapy was started before admission

Design outcomes

Primary

MeasureTime frame
Association between administration of hypotonic fluids and hospital-acquired hyponatraemia, assessed by the following: 1. Plasma sodium, potassium and osmolality in all blood samples collected at admission (T0) and 12 (T12), 24 (T24), 48 (T48) and 72 (T72) hours of intravenous fluids therapy 2. Plasma urea, creatinine and uric acid, measured in all blood samples collected at T0 and T24

Secondary

MeasureTime frame
To determine contributive factors that may increase hyponatraemia risk, assessed by the following: 1. Plasma sodium, potassium and osmolality in all blood samples collected at admission (T0) and 12 (T12), 24 (T24), 48 (T48) and 72 (T72) hours of intravenous fluids therapy. 2. Plasma urea, creatinine and uric acid, measured in all blood samples collected at T0 and T24. 3. Plasma AntiDiuretic Hormone (ADH), measured at T0. Abnormal ADH function was assessed by serum osmolality and serum sodium determinations.

Countries

Turkey

Outcome results

None listed

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