Protocol summary

Study aim
Comparison of the Effect of Dopamine and Lasix Drip in Children With Oliguria.
Design
Clinical trial phase 3. children diagnosed with oliguria and approved by a specialist physician considered as the study group. In this study, 60 children who meet the inclusion criteria will be selected. Patients will be divided into two groups, with 30 children in the dopamine group and 30 children in the Lasix group nonrandomly. Accordingly, the treatment will continue with the recovery time of the oliguria, and the time and dose required to improve the patients will be recorded.
Settings and conduct
This study will carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be not blinded.
Participants/Inclusion and exclusion criteria
Children with oliguria and consent to participate in the study enrolled to study, also with underlying kidney disease excluded from study.
Intervention groups
In the first group, dopamine at a dose of 3 microgram per kg per minutes and in second group dopamine at a dose of 0.05 milligram per kg per hours until improvement of oliguria.
Main outcome variables
Oliguria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130518013366N12
Registration date: 2019-11-07, 1398/08/16
Registration timing: prospective

Last update: 2019-11-07, 1398/08/16
Update count: 0
Registration date
2019-11-07, 1398/08/16
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
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Dopamine and Lasix Drip in Children With Oliguria.
Public title
Comparison Dopamine and Lasix Drip in Oliguria.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with oliguria Consent to participate in the study
Exclusion criteria:
Any underlying kidney disease
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.ARAKMU.REC.1398.165

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
Oliguria
Timepoint
Before and after treatment
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dopamine at a dose of 3 microgram per kg per minutes until improvement of oliguria.
Category
Treatment - Drugs

2

Description
Intervention group: Dopamine at a dose of 0.05 milligram per kg per hours until improvement of oliguria.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Maryam Qaderidehkordi
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
Maryqadridehkordi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
Anoushirvani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefichaijan
Position
Associate Professor of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
parsayousefichaijan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefichaijan
Position
Associate Professor of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
parsayousefichaijan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefichaijan
Position
Associate Professor of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
parsayousefichaijan@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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