1-Study of Clinical outcomes and serum concentration of meropenem in patients with acute kidney injury treated with two different dosing regimens
2-Determine the percentage of patients who receive two standard and adjustment regimens to get the appropriate clinical response and acceptable serum drug level
Design
Randomised Clinical Trial, parallel group
Settings and conduct
This study will be carried out in Imam Hossein Hospital of Tehran.All patients receive the standard dose of meropenem for up to 48 hours.Then blood sample is taken from patients for measurement of peak and trough concentrations of meropenem.Then patients randomly placed in one of two groups,once that receives a standard dose until the end of the treatment, and the other group receives based on the renal functionIn, between five to seven days, the blood sample is taken to measurement of peak and trough concentrations of meropenem, and daily monitoring of the clinical symptoms of the patient is performed to assess the response to treatment.
Participants/Inclusion and exclusion criteria
1- Need to be treated with meropenem
2- Minimally increase the level of creatinine from the base level by 1.5 or at least increase the creatinine level by more than 0.3mg / dl, or at least decrease by more than 25% of GFR or urinary excretion less than 0.5ml / kg / h for more than 6 hours.
3. Age older than 18 years
Intervention groups
All patients receive the standard dose of meropenem for up to 48 hours and then randomly placed in one of two groups,once that receives a standard dose until the end of the treatment, and the other group receives based on the renal function
Main outcome variables
Serum concentration of Meropenem,Clinical outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160412027346N5
Registration date:2019-01-19, 1397/10/29
Registration timing:prospective
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Shadi Ziaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
shadiziaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Clinical outcomes and serum concentration of meropenem in patients with acute kidney injury treated with two different dosing regimens
Public title
"Study of Clinical outcomes and serum concentration of Meropenem in acute kidney injury"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute kidney injury
Recepient of Meropenem
Age over 18 year
Exclusion criteria:
History of chronic kidney disease
Get chronic or emergency dialysis
History of seizure
History of allergy to beta-lactam
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block randominization,blocksizes:4 ,with using statistical 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 Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.038
Health conditions studied
1
Description of health condition studied
Acute kidney disease
ICD-10 code
N17
ICD-10 code description
Acute kidney failure
Primary outcomes
1
Description
Serum concentration of Meropenem
Timepoint
Measurement of serum concentration of Meropenem in half an hour before and one hour after infusion on three and fifth day of drug injection
Method of measurement
HPLC
Secondary outcomes
1
Description
Clinical outcomes
Timepoint
Daily
Method of measurement
Clinical Pulmonary infection Score
2
Description
Serum creatinin
Timepoint
Daily
Method of measurement
Laboratory method
Intervention groups
1
Description
Intervention group: recieving Meropenem 1 gram three times a day
Category
Treatment - Drugs
2
Description
Intervention group: recieving Meropenem with regulated dose based on daily creatinine level
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossin hospital
Full name of responsible person
Rezvan Hassanpour
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
Hassanpour@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Naderi
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0077
Fax
Email
naderi@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
Rezvan Hassanpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
Hassanpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rezvan Hassanpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
Hassanpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rezvan Hassanpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
Hassanpour@sbmu.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study all the data after blinding and statistical analysis based on what mentioned in methodology will be extracted and published online as a scientific paper
When the data will become available and for how long