Evaluation of magnesium sulfate efficacy in prevention of acute kidney injury induced by vancomycin+piperacillin-tazobactam combination
Design
This is an open-label randomized clinical trial. Fifty four adults will equally be assigned to magnesium or control group according the permuted block randomization method.
Settings and conduct
Patients of intensive care units of Imam Khomeini Hospital Complex with inclusion criteria of the study will be randomly assigned to either the magnesium or the control group.
Participants/Inclusion and exclusion criteria
Patients (18-75 years old) with no history of renal failure who are candidate to receive vancomycin + piperacillin-tazobactam regimen empirically or based on microbial culture will be included.
Intervention groups
All patients will receive vancomycin + piperacillin-tazobactam. Patients in the magnesium group will receive intravenous magnesium sulfate to achieve the target serum Mg level around 3 mg/dL and this level will be maintained for 5 days. The control group will receive the same volume of normal saline. In patients in the control group, if serum magnesium level drops to less than 1.7 mg/dl at any time of the intervention course, it will be corrected toward ≥ 1.7 mg/dl.
Main outcome variables
Incidence of acute kidney injury
General information
Reason for update
Acronym
MSIVPTN
IRCT registration information
IRCT registration number:IRCT20100228003449N26
Registration date:2019-10-20, 1398/07/28
Registration timing:registered_while_recruiting
Last update:2019-10-20, 1398/07/28
Update count:0
Registration date
2019-10-20, 1398/07/28
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of magnesium sulfate efficacy in prevention of acute kidney injury induced by vancomycin+piperacillin-tazobactam combination
Public title
Magnesium sulfate in prevention of vancomycin+piperacillin-tazobactam nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age between 18-75 years
Patients without history of renal failure
Patients with indication to receive vancomycin+piperacillin-tazobactam
Exclusion criteria:
known history of hypersensitivity reactions to vancomycin and betalactams
Pregnancy
Patients with creatinine clearance less than 60 ml/min
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done according to the blocks randomization method. Regarding to the sample size, nine blocks will be chosen. Random sequences will be created by SAS software.
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 Tehran University Of Medical Scienses
Street address
Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.TUMS.TIPS.REC.1398.080
Health conditions studied
1
Description of health condition studied
Acute Kidney Injury
ICD-10 code
N17.0
ICD-10 code description
Acute renal failure with tubular necrosis
Primary outcomes
1
Description
Incidence of acute kidney injury
Timepoint
Daily
Method of measurement
Increase in serum creatinine by 0.3 mg/dl or more than 50% from the baseline value
2
Description
Time of acute kidney injury occurrence
Timepoint
Daily
Method of measurement
Recording of incidence time
Secondary outcomes
1
Description
Length of ICU stay
Timepoint
Daily
Method of measurement
Recording of stay days
Intervention groups
1
Description
Magnesium group: This patients will receive vancomycin (15mg/kg every 8-12 hours) + piperacillin-tazobactam (4.5 g every 6 hour) concomitant with intravenous magnesium sulfate on the basis of rule of thumb (each 1g intravenous magnesium sulfate raises 0.15 mEq/l of serum magnesium) to achieve the target serum Mg level around 3 mg/dL. This level will be maintained for 5 days. Every 2 grams of magnesium sulfate will be diluted in 50 ml normal saline and will be infused over 2- hour period.
Category
Treatment - Drugs
2
Description
Control group: This patients will receive vancomycin (15mg/kg every 8-12 hours) + piperacillin-tazobactam (4.5 g every 6 hour) concomitant with the same volume of normal saline. If serum magnesium level drops to less than 1.7 mg/dl at any time of the intervention course, it will be corrected toward ≥ 1.7 mg/dl.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Boulveard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2756
Email
khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6658 1598
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6658 1598
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
ClinicalPharmacy
Street address
ایران، تهران، خیابان 16 آذر، دانشگاه علوم پزشکی تهران، دانشکده داروسازی، گروه داروسازی بالینی
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6658 1598
Email
khalilih@tums.ac.ir
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
When the data will become available and for how long
One year after finishing the study, data will be published and will be available in databases
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and meta-analysis
From where data/document is obtainable
For this you may ask Hossein Khalili through following information:
Address: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
Postal code: 1417614411
E-mail: khalilih@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks