Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/05/2007
Date assigned
28/09/2007
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Istanbul University, Faculty of Medicine (Turkey)

Sponsor details

Department of Paediatric Intensive Care
Millet Cad
Fındıkzade
Istanbul
34390
Turkey

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes