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Evaluating the effect of prolonging the infusion time on the pharmacokinetic profile, and adverse effects of Colistin

Protocol summary

Study aim
Evaluating the effect of prolonging the infusion time on the pharmacokinetic profile and adverse effects of Colistin
Design
This study is a controlled clinical trial (bioequivalence phase). In each of the intervention and control groups, 30 patients are included in the study. The entry of patients into the study is random, and the "rand" function of Excel software is used for randomization. Blinding is not done in this study.
Settings and conduct
The study will be conducted between March 2024 and March 2025 on patients admitted to Al-Zahra Hospital, affiliated with Isfahan University of Medical Sciences. People who, for any reason, receive colistin at a dose suitable for their kidney function every 12 hours and meet other criteria for entering the study, are included in the study. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
People who received colistin at a dose suitable for their kidney function every 12 hours and who meet the other criteria for entering the study, will be placed in two intervention and control groups. Inclusion criteria: 1. Age over 18 years 2. Receiving colistin with the appropriate dose of renal function, every 8 hours 3. eGFR above 50 4. No history of acute kidney injury Exclusion criteria: 5. Recent use of colistin in the last 7 days 6. Using colistin for less than 3 days 7. Simultaneous reception of other nephrotoxic drugs such as vancomycin, aminoglycosides, amphotericin B
Intervention groups
For the people in the intervention group, colistin will be administered as a long-term infusion (2 hours) and the control group will receive colistin with the usual administration method of 0.5 hours.
Main outcome variables
Colistin serum concentration, acute kidney injury

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160713028901N6
Registration date: 2024-04-10, 1403/01/22
Registration timing: prospective

Last update: 2024-04-10, 1403/01/22
Update count: 0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Shirinsadat Badri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7068
Email address
badri@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of prolonging the infusion time on the pharmacokinetic profile, and adverse effects of Colistin
Public title
Prolonged infusion time and colistin side effects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years Receiving colistin with the appropriate dose of renal function, every 8 hours eGFR above 50 No history of acute kidney injury (based on medical history)
Exclusion criteria:
Recent use of colistin in the past 7 days Use of colistin for less than 3 days Simultaneous reception of other nephrotoxic drugs such as vancomycin, aminoglycosides, amphotericin B
Age
From 18 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
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
Ethical committee in research of the faculties of pharmacy and nutrition, Isfahan University of Medi
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-03-19, 1402/12/29
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.103

Health conditions studied

1

Description of health condition studied
Acute kidney injury
ICD-10 code
N17
ICD-10 code description
Acute kidney failure

Primary outcomes

1

Description
Serum colistin concentration
Timepoint
We will collect 4 blood samples each from both the control group and the intervention group in order to obtain the AUC of colistin, in this way, we will take the first sample 15 minutes after the end of the colistin infusion to determine the peak of the drug and the fourth sample It should be taken 30 minutes before we want to inject the next infusion in order to determine the drug profile, and we take two more samples in the time between the first and fourth samples. The first sample we take should be after the fifth dose so that the level of colistin concentration in the blood has reached a steady state.
Method of measurement
We take 3cc samples in heparin tubes and centrifuge them to separate their plasma; We keep the separated plasma in the freezer at -80°C to analyze and check the samples with the help of HPLC to obtain the colistin serum concentration in each step; This measurement will be done as a service purchase from one of Tehran's research laboratories.

2

Description
Acute kidney injury
Timepoint
Immediately after receiving the first dose of colistin, and 48 hours after starting colistin
Method of measurement
Acute kidney injury will be defined according to the KDIGO criteria: an increase in serum creatinine greater than or equal to 0.3 mg/dL within 48 hours, or an increase in serum creatinine greater than or equal to 1.5 times the baseline level, or a urine volume of less than 0.5 mL/min. kg per hour for 6 hours

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For people in the intervention group, Cleistin will be administered as a long-term infusion (2 hours).
Category
Treatment - Other

2

Description
Control group: The control group will receive colistin with the usual 0.5-hour administration method.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra University Hospital
Full name of responsible person
Shirinsadat Badri
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Asgari
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8064
Fax
Email
res@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Fax
Email
badri@pharm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Fax
Email
badri@pharm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Fax
Email
badri@pharm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Demographic and clinical characteristics of patients including age, sex, body weight, current illness, past medical history, history of underlying kidney disease, other antibiotic treatments, duration of colistin use, concurrently prescribed drugs, inpatient department, and diagnosis (indication for drug use) and drug-related points including the date, time, dose and duration of injection along with the time of taking blood samples from patients will be recorded. After the end of the study, this information will be published in addition to the clinical data related to the main outcomes as well as the results of the statistical analyses.
When the data will become available and for how long
The start of the data access period will be in October 2025, after the defense of the thesis and the publication of the article resulting from the project.
To whom data/document is available
Researchers, students and teachers working in academic and medical institutions
Under which criteria data/document could be used
In order to design similar studies or use the results of this study for systematic review and meta-analysis of data
From where data/document is obtainable
Online scientific databases, including PubMed, Web of Science, Scopus, and... Website of Central Library of Isfahan University of Medical Sciences, address: https://diglib.mui.ac.ir/ or by sending an email to the corresponding author: badri@pharm.mui.ac.ir
What processes are involved for a request to access data/document
Searching with keywords in scientific internet databases, Search through the title of the project on the website of the digital library of Isfahan University of Medical Sciences. Internet search on the website of the magazine where the article from the project is published.
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