Effect of fast intravenous serum therapy on hospital admisson rate of children with refractory vomitting and gastroenteritis referring to Tabriz Children's Hospital
Our aim in this study is to evaluate the effect of fast intravenous serum therapy on hospital admission rate of children with gastroenteritis. In a randomized and unicentral clinical trial 70 children aged between 2 to 12 from both genders and with moderate gastroenteritis referring to emergency ward of Tabriz Children's Hospital would be involved. Key inclusion criteria would include children aged between 2 to 12 with diarrhea and vomiting which have not responded well to routine oral therapies; not to have electrolite imbalance; not to have severe dehydration; to fulfill an informed consent and exclusion criteria would be to have mild or severe dehydration; to have electorlite imbalance; in shock patients; patients with vomiting or diarrhea alone. Patients will randomly be divided into two control or case group each with 35 subjects. In control group patients will be admitted and visited by a specialist every day and in the case group patients will be treated with intravenous crystalloid solution 30 ml/kg infusion within 2 hours and then visited by a pediatrician to see if they need to be admitted to the internal ward. Primary outcome measures includes skin turgor, level of mucus dryness and desire to drink water; and secondary outcome measure would be occurrence of vomiting after intravenous therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110247892N1
Registration date:2012-05-03, 1391/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-03, 1391/02/14
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-02, 1391/01/14
Expected recruitment end date
2013-01-03, 1391/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fast intravenous serum therapy on hospital admisson rate of children with refractory vomitting and gastroenteritis referring to Tabriz Children's Hospital
Public title
Does fast injection of therapeutic liquids lead to reduction in admission rate of children with gastroenteritis?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (2 to 12 year old children with diarrhea and vomiting which have not responded well to routine oral therapies; not to have electrolite imbalance; not to have severe dehydration; to fulfill an informed consent)
Exclusion criteria: (patients with mild or severe dehydration; to have electorlite imbalance; in shock patients; patients with vomiting or diarrhea alone)
Age
From 2 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Postal code
Approval date
2011-11-23, 1390/09/02
Ethics committee reference number
5/4/6665
Health conditions studied
1
Description of health condition studied
Infective gastroenteritis
ICD-10 code
A09.0
ICD-10 code description
Other and unspecified gastroenteritis of infectious origin
Primary outcomes
1
Description
Skin turgor
Timepoint
At the first time visited in the emergency ward, after receiving intravenous therapy.
Method of measurement
Physical examination by a pediatrician
2
Description
Mucosal dryness
Timepoint
At the first time visited in the emergency ward, after receiving intravenous therapy.
Method of measurement
Physical examination by a peditrician
3
Description
Desire to drink water
Timepoint
At the first time visited in the emergency ward, after receiving intravenous therapy.
Method of measurement
Physical examination by a pediatrician
Secondary outcomes
1
Description
Vomiting
Timepoint
While receiving intravenous serum or after receiving it
Method of measurement
Objective observation by a pediatrician
Intervention groups
1
Description
Control group: Patients in this group will be admitted to the internal ward of the hospital and treated as appropriate
Category
Treatment - Drugs
2
Description
Intervention group: patients in this group will receive an intravenous crystalloid 30 ml/kg within 2 hours and then visited by a pediatrician to see if they need a hospital admission to internal wards.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Anoosh Azarfar, Assistant professor, Subspecialist in children's nephrology
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Assistant professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
azarfar132@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Assistant professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
azarfar132@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Assistant professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
Fax
Email
azarfar132@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)