English Abstract
Objectives: Investigating the development of hyponatremia after administration of hypotonic (1/3-2/3) or isotonic (normal saline) maintenance intravenous fluid in children hospitalized in urology ward and undergone surgical operations.Total number of patients are 150 and any child admitted in urology ward undergoing surgery is included in this study.
Methods: Randomized control study is conducted in Children Medical Center Hospital of Tehran, Iran. The prevalence of hyponatremia before and 6 hours after finishing of surgery will be determined in both groups. Other characteristics of the patients such as age, gender, duration of hospitalization, other concomitant electrolyte disturbances and symptoms pertaining to hypervolemia are also considered. The incidence of intravenous fluid therapy induced hyponatremia will be analyzed in different categories of patients. Those with underlying renal problems, liver diseases, cardiac problems, neurogenic bladder, diabetes melitus and diabetes insipidous are excluded from study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122720448N1
Registration date:2015-06-23, 1394/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-23, 1394/04/02
Registrant information
Name
Mastaneh Moghtaderi
Name of organization / entity
Tehran University of Medical Science, Chilren Medical Center Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 5580
Email address
drmoghtaderi@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of postoperative hyponatremia in patients admitted in urology ward with two different intravenous fluids.
Public title
Evaluation of postoperative hyponatremia in patients admitted in urology ward with two different intravenous fluids.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Addmission in urology ward and undergoing surgery
Exclusion criteria: underlying renal disease ; liver disease ; cardiac problems ; nurogenic bladder ; diabetes melitus ; diabetes incipidous
Age
From 1 month old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd. Ghods Corner
City
Tehran
Postal code
Approval date
2015-02-17, 1393/11/28
Ethics committee reference number
93-03-184-27280-135489
Health conditions studied
1
Description of health condition studied
Hyponatremia
ICD-10 code
E87.1
ICD-10 code description
Hypo-osmolality and hyponatraemia
Primary outcomes
1
Description
Na level of serum after surgery
Timepoint
befor and after surgery
Method of measurement
blood sample assay
Secondary outcomes
1
Description
Clinical signs of hyponatremia
Timepoint
pre and post surgery state
Method of measurement
evaluation of serum Na
Intervention groups
1
Description
In the first group like previous after checking serum level of Na we give them 1/3 - 2/3 fluid therapy and six hours after surgery we control serum Na level again to asses hyponatrmia incidence.
Category
Treatment - Drugs
2
Description
In the second group like others after checking serum level of Na we give them normal saline serum therapy and six hours after surgery we control serum Na level again to asses hyponatrmia incidence in this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Dr. Mastaneh Moghtaderi
Street address
Gharib street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Yunesian
Street address
Keshavarz Blvd, Ghods Corner
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Children Medical Ccenter Hospital
Full name of responsible person
Dr. Mastaneh Moghtaderi
Position
Pediatric Nephrologyst
Other areas of specialty/work
Street address
Gharib street
City
Tehran
Postal code
Phone
+98 21 6147
Fax
Email
dmoghtaderi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children Medical Center Hhospital
Full name of responsible person
Dr. Mastaneh Moghtaderi
Position
Pediatric Nephrologyst
Other areas of specialty/work
Street address
Gharib Street
City
Tehran
Postal code
Phone
+98 21 6147
Fax
Email
drmoghtaderi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children Mmedical Center Hospital
Full name of responsible person
Dr. Mastaneh Moghtaderi
Position
Pediatric Nephrologyst
Other areas of specialty/work
Street address
Gharib street
City
Tehran
Postal code
Phone
+98 21 6147
Fax
Email
drmoghtaderi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)