This is a Randomized double blind clinical trial
Inclusion criteria were age 6 months to 14 years; without Diabetes Insipidus; hypothalamic diseases; pituitary diseases; renal disease; acute pulmonary disease; malnutrition ; cardiac diseases; hyponatremia at T0; hyperatremia at T0 and Exclusion criteria were hypernatremia(sodium above 150); Hyponatremia ( Sodium Lower than 130); toxicity; low blood pressure. .
Sample size was indicated 112 children aged 6 months to 14 years
First outcome were indicated as hyponatremia in isonatremic and hyponatremic group
T0 Isonatremic patients are included in the study AND based on block randomization were divided into two groups, A and B.
For Group A First,20cc/kg isotonic saline (0.9%)were administered which could be repeated for 3 times, then 5% dextrose in isonatremic saline(0.9%) with 20meq/Lit were administered as loading and maintenance fluid and For Group B First,20cc/kg isotonic saline (0.9%)were administered which could be repeated for 3 times, then 5% dextrose in isonatremic saline(0.9%) with 20meq/Lit were administered as loading and maintenance fluid were administered . patients were assessed at 4 hours and 24 hours after reception.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211261545N2
Registration date:2012-12-23, 1391/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Hamidreza Badeli
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 9523
Email address
badeli@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research of Guilan University of Medical Sciences
Expected recruitment start date
2012-12-20, 1391/09/30
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the comparison between isotonic versus hypotonic rehydration therapy on the level of plasma sodium in children with gastroenteritis
Public title
effect of normal saline on diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 6 months to 14 years; without Diabetes Insipidus; hypothalamic diseases; pituitary diseases; renal disease; acute pulmonary disease; malnutrition ; cardiac diseases; hyponatremia at T0; hyperatremia at T0
Exclusion criteria: hypernatremia(sodium above 150); Hyponatremia ( Sodium Lower than 130); toxicity; low blood pressure.
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for research -Guilan University of Medical Science
Street address
shahid siadati street
City
rasht
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
1910095601
Health conditions studied
1
Description of health condition studied
gasteroenteritis
ICD-10 code
K52.9
ICD-10 code description
Noninfective gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
hyponatremia in isonatremic group
Timepoint
4 hours and 24 hours after reception
Method of measurement
the level ofserum sodium concentrationwere evaluated by ise method in electrolyte analyser
2
Description
hyponatremia in hyponatremic group
Timepoint
4 hours and 24 hours after reception
Method of measurement
the level ofserum sodium concentrationwere evaluated by ise method in electrolyte analyser
Secondary outcomes
empty
Intervention groups
1
Description
First,20cc/kg isotonic saline (0.9%)were administered which could be repeated for 3 times, then 5% dextrose in hypotonic saline(0.45%) with 20meq/Lit were administered as loading and maintenance fluid
Category
Treatment - Other
2
Description
First,20cc/kg isotonic saline (0.9%)were administered which could be repeated for 3 times, then 5% dextrose in isonatremic saline(0.9%) with 20meq/Lit were administered as loading and maintenance fluid
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Dr Hamidreza Badeli
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research -Guilan University of Medical Science
Full name of responsible person
Dr Abdorrasoul Sobhani
Street address
Shahid Siadati Street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research -Guilan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Nnephrologist and associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Siadati Street
City
Rasht
Postal code
Phone
+98 13 1322 9902
Fax
Email
badeli@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Nephrologist and Associate Professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Siadati st
City
Rasht
Postal code
Phone
+98 13 1322 9902
Fax
Email
badeli@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Nephrologist and Associate Professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Siadati Street
City
Rasht
Postal code
Phone
+98 13 1322 9902
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)