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10 February 2012
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| [ Print-friendly version ] |
| Which intravenous fluid should be given for hospitalized patients?: A prospective randomised study |
| ISRCTN | ISRCTN75155444 |
| ClinicalTrials.gov identifier | |
| Public title | Which intravenous fluid should be given for hospitalized patients?: A prospective randomised study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | The hypothesize of the study is that in sick children, moderately hypotonic fluids (such as fluids contain 77 mmol/L sodium) are better tolerated (i.e. induce less hyponatraemia without the risk of hypernatraemia) than conventional intravenous fluids that contain 34 mmol/L sodium. |
| Lay summary | |
| Ethics approval | Ethical Board of Istanbul University, Istanbul Faculty of Medicine, approved on 13 June 2005. Ref: 2005/526. |
| Study design | Randomized controlled trial. |
| Countries of recruitment | Turkey |
| Disease/condition/study domain | Hyponatraemia |
| Participants - inclusion criteria | All children aged between 3 months to 16 years old who received intravenous fluids |
| Participants - 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 |
| Anticipated start date | 15/06/2005 |
| Anticipated end date | 26/05/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 100 |
| 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. Randomization was performed separately for children on the ward and children in the Paediatric Intensive Care Unit (PICU).
Arm 1: 0.2% sodium in 5% dextrose Arm 2: 0.3% sodium in 3.3% dextrose Arm 3: 0.45% sodium in 5% dextrose When hyponatraemia developed in any group during the therapy intravenous fluid sodium composition was increased and fluid therapy was decreased to 80% of the initial volume. |
| Primary outcome measure(s) |
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 outcome measure(s) |
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. |
| Sources of funding | Mainly investigator-funded with support from Ege Medical Company (Turkey) |
| Trial website | |
| Publications | |
| Contact name | Prof Metin Karaböcüoğlu |
| Address |
Istanbul University
Istanbul Faculty of Medicine Department of Paediatric Intensive Care Millet Cad Fındıkzade |
| City/town | Istanbul |
| Zip/Postcode | 34390 |
| Country | Turkey |
| Tel | +01190 5332341818 |
| Fax | +01190 2123698564 |
| mkara63@hotmail.com | |
| Sponsor | Istanbul University, Faculty of Medicine (Turkey) |
| Address |
Department of Paediatric Intensive Care
Millet Cad Fındıkzade |
| City/town | Istanbul |
| Zip/Postcode | 34390 |
| Country | Turkey |
| Date applied | 14/05/2007 |
| Last edited | 10/03/2008 |
| Date ISRCTN assigned | 28/09/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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