Which intravenous fluid should be given for hospitalized patients?: A prospective randomised study
| ISRCTN | ISRCTN75155444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75155444 |
| Protocol serial number | N/A |
| Sponsor | Istanbul University, Faculty of Medicine (Turkey) |
| Funder | Mainly investigator-funded with support from Ege Medical Company (Turkey) |
- Submission date
- 14/05/2007
- Registration date
- 28/09/2007
- Last edited
- 10/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Istanbul University
Istanbul Faculty of Medicine
Department of Paediatric Intensive Care
Millet Cad
Fındıkzade
Istanbul
34390
Türkiye
| Phone | +01190 5332341818 |
|---|---|
| mkara63@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Ethical Board of Istanbul University, Istanbul Faculty of Medicine, approved on 13 June 2005. Ref: 2005/526. |
| Health condition(s) or problem(s) studied | Hyponatraemia |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Intravenous Fluid |
| Primary outcome measure(s) |
Association between administration of hypotonic fluids and hospital-acquired hyponatraemia, assessed by the following: |
| Key secondary outcome measure(s) |
To determine contributive factors that may increase hyponatraemia risk, assessed by the following: |
| Completion date | 26/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | All children aged between 3 months to 16 years old who received intravenous fluids |
| Key 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 |
| Date of first enrolment | 15/06/2005 |
| Date of final enrolment | 26/05/2006 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
34390
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
