Evaluation the effect of prolonging the duration of administration of Colistin infusion on the Colistin-induced nephrotoxicity
Design
This study is a clinical trial. The number of 72 patients in Amir al-Momenin hospital in Arak who are candidates for colهstin will be included in the study. They were randomly divided into 2 groups
Settings and conduct
This study is a clinical trial. The number of 72 patients in Amir al-Momenin hospital in Arak who are candidates for colistin will be included in the study.
In the intervention group, the duration of colistin infusion is 1 million units in 2 hours.
Participants/Inclusion and exclusion criteria
At least 18 years old
A patient receiving colistin
Infection with Multidrug resistance organism
Sputum culture be positive with Acinetobacter baumannii , Klebsiella pneumoniae
Intervention groups
Intervention group (Colistin infusion: 1 million units in a 2 hours)
Control group (Infusion in 20 minutes)
Main outcome variables
drug toxicity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230225057533N1
Registration date:2023-05-27, 1402/03/06
Registration timing:registered_while_recruiting
Last update:2023-05-27, 1402/03/06
Update count:0
Registration date
2023-05-27, 1402/03/06
Registrant information
Name
Sina Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3314 1382
Email address
h99.sina@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-04, 1401/12/13
Expected recruitment end date
2023-12-04, 1402/09/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of prolonging the duration of administration of Colistin infusion on the Colistin-induced nephrotoxicity
Public title
Evaluation the effect of prolonging the duration of administration of Colistin infusion on the Colistin-induced nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Infection with Multidrug resistance organism
Sputum culture be positive with Acinetobacter baumannii , Klebsiella pneumoniae
Exclusion criteria:
Discontinue treatment with colistin
Receiving other nephrotoxic drugs at the same time
Oliguria (urine output less than 500 cc in 24 hours)
Hypotension due to a reason other than sepsis (embolism, MI, hypovolemic shock),
receiving NSAIDs
Receive albumin
receiving contrast agents
Estimated glomerular filtration rate (eGFR) less than 5 mL/min/1.73 m2
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a table of random numbers in dividing groups into intervention and control groups
Randomization method: simple randomization. Randomization is done in a simple way using a table of random numbers. In this way, odd numbers are assigned to the intervention group and even numbers are assigned to the control group. This work should be continued until the number of samples is completed.
Researcher moves from a selected point randomly with a pen.In this case, it may be divided into two groups of numbers larger or smaller than the total number of samples.Researcher should only confirm numbers smaller than the total samples.
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
Arak University of Medical Sciences (Research Ethics Committee)
Street address
No.1,Faculties Building,University Complex of the Prophet (PBUH),Basij Square ,Arak
City
Arak
Province
Markazi
Postal code
38149578558
Approval date
2023-01-07, 1401/10/17
Ethics committee reference number
IR.ARAKMU.REC.1401.295
Health conditions studied
1
Description of health condition studied
Nephrotoxicity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level ofCreatinine and BUN
Timepoint
Daily
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infusion of colistin 1million unit in 2 hours
Category
Treatment - Drugs
2
Description
Control group: Control group: Clostin drug infusion for 20 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al momenin hospital
Full name of responsible person
ِDr Somayeh Shabib
Street address
No 1, Amir al-Momenin (AS) educational and therapeutic center, Basij Square-next to medical school,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3619
Email
Shabib333@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Amani
Street address
No.1, Faculties Building,University Complex of the Prophet (PBUH),Basij Square ,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 0000
Email
dramani.ortho@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
Dr Somayeh Shabib
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacotherapy
Street address
No.1, Faculties Building,University Complex of the Prophet (PBUH),Basij Square ,Arak
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
009833838392
Email
shabib333@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Somayeh Shabib
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacotherapy
Street address
No.1, Faculties Building,University Complex of the Prophet (PBUH),Basij Square ,Arak
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3383 8392
Email
shabib333@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sina Hashemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 1 , Yas 2 Alley , Habib Ibn Mazaher Alley , Shahid Shiroudi St
City
َArak
Province
Markazi
Postal code
3819768481
Phone
+98 86 3314 1382
Email
h99.sina@gmail.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