This study evaluates the effect of Dopamine on the appropriate time of the first urination and the gradual excess in urine volume until reaching the normal urine output in oliguric children. At the Amir kabir pediatric hospital of Arak, 120 oliguric patients are non-randomly selected and divided into two intervention and control groups. Patients with any kinds of kidney malignancy, the chronic kidney diseases and the patients who have been under the chronic kidney drug therapy will be excluded. For the intervention group, Dopamine at the dose of 3µg/kg/min is prescribed via intravenous injection until the beginning of the first urination and this drug therapy will be continued until reaching the normal urine output volume. For the control group, normal saline at the dose of 20cc/kg/min will be prescribed via intravenous injection and like the intervention group this serum therapy will be continued until first urination and normal urine output volume. Finally, the exact time of the first urination and the time of gaining the normal urine output due to correction of the body electrolyte disturbances and kidney function will be compared and evaluated statistically. This study is not blinded because of the method of selection of the subjects and the use of drugs (dopamine and normal saline).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011513366N6
Registration date:2017-10-05, 1396/07/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research ,Arak University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dopamine on the appropriate time of urination in oliguric patients.
Public title
The effect of dopamine on the appropriate time of urination in oliguric patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: acute kidney failure.
Exclusion criteria : chronic underlying disease or malignancy; consuming another concurrent drug
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients are non randomly divided in to two groups receiving intra venous dopamine(case) and intravenous fluid therapy(Control).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Arak University of Medical Sciences
Street address
Faculty of Medicine, Sardasht, Taleqani street, Arak
City
Arak
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.ARAKMU.REC.1395.222
Health conditions studied
1
Description of health condition studied
oliguria
ICD-10 code
R34
ICD-10 code description
Anuria and oliguria
Primary outcomes
1
Description
The proper disposal of urine and oliguric recovery
Timepoint
Before and after treatment
Method of measurement
questionnaire
Secondary outcomes
1
Description
Electrolyte disturbances and kidney function
Timepoint
Before and after treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group : Dopamine at a dose of 3 microgram/kg per minutes until improvement of oliguria.
Category
Treatment - Drugs
2
Description
Control group :Routine classical drug therapy(Fluid therapy with normal saline) until improvement of oliguria.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak AmirKabir Hospital
Full name of responsible person
Dr. Vahab Ghanbari
Street address
Amir Kabir Hospital, Rahe Ahan Street, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Faculty of Medicine, Sardasht, Taleqani street, Arak
City
Arak
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,Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr.Parsa Yousefi
Position
Pediatrics Nephrologist
Other areas of specialty/work
Street address
Amirkabir Hospital, Rahe ahan street, Arak
City
Arak
Postal code
3819838453
Phone
00
Fax
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Vahab Ghanbari
Position
Pediatrics resident
Other areas of specialty/work
Street address
Amirkabir Hospital, Rahe ahan street, Arak
City
Arak
Postal code
Phone
+98 86 3402 0237
Fax
Email
vgirsh66@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Vahab Ghanbari
Position
Pediatrics resident
Other areas of specialty/work
Street address
Amirkabir Hospital, Rahe ahan street, Arak
City
Arak
Postal code
Phone
+98 86 3402 0237
Fax
Email
vgirsh66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)