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Evaluating the effect of intravenous magnesium sulphate for prevention of colistin induced Acute Kidney Injury

Protocol summary

Study aim
The main objective: to evaluate the effect of intravenous magnesium sulfate for prevention of colistin induced Acute Kidney Injury (AKI). The specific objective: determining the laboratory information (Mg, BUN and Cr), occurrence of AKI and clinical outcomes (escalation or de-escalation of therapy, length of hospitalization and mortality) of patients receiving colistin and comparing it with colistin + magnesium group.
Design
Two arm parallel group block randomized clinical trial, phase 3 on 96 patients.
Settings and conduct
Patients receiving colistin in Loghman Hakim Hospital who meet inclusion criteria, are divided into 2 equal groups of intervention and control. Each group has 2 blocks of without & with vancomycin to equalize the effect of other nephrotoxic antibiotics. Patients are evaluated 1 week; daily for occurrence of AKI (serum Cr, urinary output) and magnesium level. Exclusion criteria is non-renal AKI, receiving amphotericin or vitamin C, hypo/hypermagnesemia, death, discharge. Secondary outcomes are length of hospitalization, regimen change and death.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, GFR greater than 60 (ml/min), indication of colistin therapy, and magnesium blood level of greater than 1.9 and less than 3 (mg/dl). Non-inclusion criteria: pregnancy.
Intervention groups
Intervention group: colistin with a loading dose of 9-12 mIU as 1-hr infusion and daily maintenance dose of 9-12 mIU divided into 2 infusions & 1hour before each dose of colistin, 1hr infusion of 2g intravenous magnesium sulfate (dissolved in 50 ml of normal saline). Control group: colistin the same as intervention group with no intravenous magnesium.
Main outcome variables
The main outcome of this study: occurrence of Acute Kidney Injury in the first week of colistin therapy (KIDIGO criteria); with variables of serum creatinine and urinary output.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130917014693N15
Registration date: 2023-01-12, 1401/10/22
Registration timing: prospective

Last update: 2023-01-12, 1401/10/22
Update count: 0
Registration date
2023-01-12, 1401/10/22
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of intravenous magnesium sulphate for prevention of colistin induced Acute Kidney Injury
Public title
Evaluating the effects of magnesium in colistin nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with indication of colistin therapy patients with GFR> 60ml/min patients with magnesium blood level between 1.9 and 3 mg/dl
Exclusion criteria:
patients younger than 18 years patients with GFR< 60ml/min patients with magnesium blood level of less than 1.9 or more than 3 mg/dl Pregnant patients
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method with aim of elimination of the nephrotoxic effects of vancomycin (the other routinely used nephrotoxic antibiotics) is used. Therfore, this study is designed in 2 blocks of "with and without vancomycin". In each block (with an equal number of patients), patients are placed in two control and intervention groups using a table of random numbers in a ratio of 1:1. The calculated number of samples is 96 patients, which are numbered from 1 to 96 according to the sampling time. To use the table of random numbers, a column and a row are randomly selected, and the 2 digits on the left side of the crossing point is the first selected number. A hypothetical plus is drawn from that number and the numbers placed in that plus are selected. This process continues until half of the total number of samples (48 numbers) is selected, and this numbers will determine the intervention group. The first 24 numbers will be in the intervention group of "with vancomycin" block and the second 24 numbers will be in theintervention group of "without vancomycin" block.
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 shahid beheshti university of medical sciences
Street address
3rd floor, medical school, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.134

Health conditions studied

1

Description of health condition studied
Acute Kidney Injury
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified

Primary outcomes

1

Description
Acute Kidney Injury occurrence
Timepoint
Daily during the first week of colistin therapy
Method of measurement
The Kidney Disease Improving Global Outcomes (KDIGO) criteria for Acute Kidney Injury

Secondary outcomes

1

Description
Escalation or de-escalation of therapy
Timepoint
Daily during the first week of colistin therapy
Method of measurement
Colistin daily dose observation

2

Description
Length of hospitalization
Timepoint
At the time of discharge
Method of measurement
Counting the number of days

3

Description
Death
Timepoint
Daily
Method of measurement
Records Observation

Intervention groups

1

Description
Intervention group: Colistin therapy begins with a dose of 9-12 million IU as 1-hr infusion and maintenance therapy continues after 12 hours of the loading dose, with a daily dose of 9-12 million IU divided into two infusions with 12-hour interval. In the intervention group, one hour before receiving each dose of colistin, 2g (16~mEq) intravenous magnesium sulfate (dissolved in 50 ml of normal saline) is infused within one hour.
Category
Prevention

2

Description
Control group: Colistin therapy begins with a dose of 9-12 million IU as 1-hr infusion and maintenance therapy continues after 12 hours of the loading dose, with a daily dose of 9-12 million IU divided into two infusions with 12-hour interval.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Zahra Sahraei
Street address
Loghman Hakim hospital, Kamali Street, Lashgar Crossroads, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Web page address
https://lhmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
3 rd floor, School of Medicine, Arabi Street, Yaman street, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valieasr St, Niyayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
z.sahraei@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
z.sahraei@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sareh Hosseini
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
Hosseini.sare@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
All data can potentially be shared after blinding.
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
Academic institution's researchers
Under which criteria data/document could be used
Research purposes and meta-analysis
From where data/document is obtainable
Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, South Kargar St, Tehran
What processes are involved for a request to access data/document
Official letter to researchers
Comments
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