Which intravenous fluid should be given for hospitalized patients?: A prospective randomised study
| ISRCTN | ISRCTN75155444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75155444 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Metin Karaböcüoğlu
Scientific
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
| Study design | Randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Intravenous Fluid |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 15/06/2005 |
| 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 number of participants | 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
Istanbul University
Istanbul
34390
Türkiye
34390
Türkiye
Sponsor information
Istanbul University, Faculty of Medicine (Turkey)
University/education
University/education
Department of Paediatric Intensive Care
Millet Cad
Fındıkzade
Istanbul
34390
Türkiye
"ROR" |
https://ror.org/03a5qrr21 |
|---|
Funders
Funder type
Other
Mainly investigator-funded with support from Ege Medical Company (Turkey)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
