Comparing effect of two methods of vancomycin dosing on clearance of systemic inflammatory responses in septic patients
Design
This is a open-label randomized clinical trial. Forty adults with diagnosis of sepsis will equally be assigned to intervention or control group according permuted block randomization method.
Settings and conduct
Critically ill adult patients with diagnosis of sepsis and augmented renal clearance who admitted to general ICU of Imam Khomeini Hospital will be evaluated for eligibility. Forty patients will equally be assigned to intervention or control group according the permuted block randomization method. Vancomycin dose in patients in the intervention group will be calculated according to AUC/MIC index. In patients in the control group vancomycin dose will be calculated according to the serum trough concentration. Duration of intervention is 5 days.
Participants/Inclusion and exclusion criteria
Patients with sepsis older than 18 years of age who have augmented renal clearance will be included in this study
Intervention groups
Vancomycin dose in this group will be calculated using AUC/MIC index. Vancomycin AUC will be assumed based on the vancomycin peak and trough serum concentrations. MIC value will be considered 1.5 mg/l (attained from local data)
Main outcome variables
Attaining serum target concentration, clearance of systemic inflammatory responses and vancomycin renal safety are main outcomes. Target of vancomycin dose in the intervention group is AUC/MIC>=400 and in the control group is serum trough level of 15-20 mg/l.
General information
Reason for update
Acronym
VIA
IRCT registration information
IRCT registration number:IRCT20100228003449N24
Registration date:2018-07-21, 1397/04/30
Registration timing:prospective
Last update:2018-07-21, 1397/04/30
Update count:0
Registration date
2018-07-21, 1397/04/30
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
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating effect of optimizing vancomycin dosing according to AUC/MIC on systemic inflammatory responses syndrome (SIRS) in septic patients
Public title
Optimizing vancomycin dosing in septic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with sepsis
Patients with augmented renal clearance
Patients with vancomycin indication
Serum creatinine less than 1.3 mg/dl
Exclusion criteria:
Age less than 18 years old and more than 75 years old
Receiving concomitant nephrotoxic agents
Pregnancy
Patients with vancomycin contraindications
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization unit: Block randomization
Randomization tool: SAS statistical software, sealed envelope
How to create a random sequence: SAS statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Use non-transparent sealed envelopes with random sequences
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
-
Approval date
2018-07-05, 1397/04/14
Ethics committee reference number
IR.TUMS.TIPS.REC.1397.007
Health conditions studied
1
Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified
Primary outcomes
1
Description
Access vancomycin target concentration
Timepoint
Days 2-5
Method of measurement
Chemiluminescent immunoassay (CLIA)
2
Description
Clearance of systemic inflammatory response syndrome
Timepoint
Daily
Method of measurement
Evaluating vital signs, hemodynamic parameters and laboratory tests
Secondary outcomes
1
Description
Vancomycin induced nephrotoxicity
Timepoint
Daily measurement of serum creatinine
Method of measurement
0.5 mg/dl or 50% increase in serum creatinine from the baseline value
Intervention groups
1
Description
Vancomycin dosing according to AUC/MIC index
Category
Treatment - Drugs
2
Description
Vancomycin dosing according to serum trough level
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital complex
Full name of responsible person
Hossein khalili afousi
Street address
Keshavarz Blvd
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 afousi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
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
-
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 afousi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
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
-
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 afousi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
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
-
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 end of 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
Contact scientific responsible person for the clinical trial as needed
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.
Comments
Data sharing is according to permission from the sponsor.