Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment: September 2006 to April 2008 Analysis: May and June 2008 Pediatric ward and Pediatric intensive care unit in a tertiary care referral hospital in North India

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were stratified based on their age in to three groups (age 3 months to 1 year, 1-5 years, 6-12 years) and stratified randomization was used.

Reporting Groups

	Description
Dextrose Normal Saline	Normal saline in 5% dextrose at standard maintenance rate
Fluid Restriction Group	Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
Hypotonic Saline	N/5 saline in 5% dextrose at standard maintenance rate

Participant Flow:   Overall Study

	Dextrose Normal Saline	Fluid Restriction Group	Hypotonic Saline
STARTED	58	53	56
COMPLETED	58	53	56
NOT COMPLETED	0	0	0

Reporting Groups

	Description
Dextrose Normal Saline	Normal saline in 5% dextrose at standard maintenance rate
Fluid Restriction Group	Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
Hypotonic Saline	N/5 saline in 5% dextrose at standard maintenance rate

Baseline Measures

	Dextrose Normal Saline	Fluid Restriction Group	Hypotonic Saline	Total
Number of Participants   [units: participants]	58	53	56	167
Age   [units: participants]
<=18 years	58	53	56	167
Between 18 and 65 years	0	0	0	0
>=65 years	0	0	0	0
Age   [units: years] Mean ± Standard Deviation	3  ± 0.44	3  ± 0.36	4  ± 0.28	3.33  ± 0.56
Gender   [units: participants]
Female	36	35	43	114
Male	22	18	13	53
Region of Enrollment   [units: participants]
India	58	53	56	167

1.  Primary:

Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)   [ Time Frame: 72 hrs ]

2.  Secondary:

Incidence of Hypernatremia (Serum Sodium >150 mmol/L)   [ Time Frame: 72 hrs ]

3.  Secondary:

Incidence of Symptomatic Hyponatremia   [ Time Frame: 72 hrs ]

4.  Secondary:

Incidence of Symptomatic Hypernatremia   [ Time Frame: 72 hrs ]