Contact information
Type
Scientific
Primary contact
Prof Metin Karaböcüoğlu
ORCID ID
Contact details
Istanbul University
Istanbul Faculty of Medicine
Department of Paediatric Intensive Care
Millet Cad
Fındıkzade
Istanbul
34390
Turkey
+01190 5332341818
mkara63@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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.
Ethics approval
Ethical Board of Istanbul University, Istanbul Faculty of Medicine, approved on 13 June 2005. Ref: 2005/526.
Study design
Randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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 names
Intravenous Fluid
Primary outcome measures
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 trial start date
15/06/2005
Overall trial end date
26/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All children aged between 3 months to 16 years old who received intravenous fluids
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
100
Participant 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
Recruitment start date
15/06/2005
Recruitment end date
26/05/2006
Locations
Countries of recruitment
Turkey
Trial participating centre
Istanbul University
Istanbul
34390
Turkey
Funders
Funder type
Other
Funder name
Mainly investigator-funded with support from Ege Medical Company (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary