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Evaluation of prevalence of Augmented renal clearance (ARC) and serum concentration of Meropenem with two different dosing regimens in critically ill patients

Protocol summary

Study aim
Evaluation of prevalence of Augmented renal clearance (ARC) and serum concentration of Meropenem with two different dosing regimens in patients with ARC
Design
Pre-post intervention, randomized, open label clinical trial
Settings and conduct
On the first day of the study, patients will be evaluated according to Augmented renal clearance (ARC) and Augmented renal clearance in trauma intensive Care (ARCTIC) scoring systems and for patients who categorized as high-risk based on these systems, 12-hour creatinine clearance will be measured on days 0, 3, 7,10 and 14. Subjects with creatinine clearance 130 ml/min and above will be recruited. For patients who will be treated with meropenem 3g daily (1 gram three times a day), based on physician in charge decision, after 24 hours, blood samples will be drawn, one hour after end of the infusion (peak concentration) and half an hour before receiving the next dose (trough concentration), in order to measure the meropenem serum concentration.Then the dosage adjustment will be done and will increase to 6g daily (2 grams three times a day). Next set of same blood samples will be drawn 24 hours after dose change to measure new peak and trough meropenem serum concentrations.
Participants/Inclusion and exclusion criteria
Inclusion criteria: serum creatinin 0.7mg/dl and lower,Sequential Organ Failure Assessment (SOFA) score 4 and lower , Augmented renal clearance (ARC ) scoring 7 and higher ,Augmented renal clearance in trauma intensive Care (ARCTIC) scoring 7 and higher, 12 hour - Clearance creatinin 130 ml/min and higher Exclusion criteria: Age lower than 18 , Pregnancy and Lactation
Intervention groups
First receive meropenem(Ronak daru) with a dose of 1 g three times a day infusion over 4 hour , then dose up to to 2 g three times a day.
Main outcome variables
Serum concentration of meropenem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120703010178N19
Registration date: 2020-02-07, 1398/11/18
Registration timing: registered_while_recruiting

Last update: 2020-02-07, 1398/11/18
Update count: 0
Registration date
2020-02-07, 1398/11/18
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prevalence of Augmented renal clearance (ARC) and serum concentration of Meropenem with two different dosing regimens in critically ill patients
Public title
Augmented renal clearance (ARC) and Meropenem concentration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
serum creatinin 0.7mg/dl and lower Sequential Organ Failure Assessment (SOFA) score 4 and lower Augmented renal clearance (ARC ) scoring 7 and higher Augmented renal clearance in trauma intensive Care (ARCTIC) scoring 7 and higher 12 hour - Clearance creatinin 130 ml/min and higher
Exclusion criteria:
Pregnancy and Lactation Age lower than 18 yr
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: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, Faculties of Pharmacy and Nursin
Street address
Faculty of pharmacy, Niayesh and Vali-e-Asr junction
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.164

Health conditions studied

1

Description of health condition studied
Augmented renal clearance (ARC)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum concentration of Meropenem
Timepoint
1 hour after end of infusion, 30 minute before next dose
Method of measurement
HPLC

2

Description
Serum creatinin
Timepoint
Daily from the beginning of the study to the 14th day of the study
Method of measurement
Laboratory apparatus, Calorimetric method

3

Description
Urine volume
Timepoint
0,3,7,10,14 day of enter to study
Method of measurement
Urine bag

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with creatinine clearance of more than or equal to 130 ml/min, based on 12-hr urine collection, who receive meropenem (Ronakpharm, Iran) will be recruited in the study. Study subjects will receive meropenem, 1 g three times daily as 4-hr infusion. After 24 hours, at steady state, two blood samples, 1 hour after termination of infusion and 0.5 hour before next dose, will be gathered. Then the dose of meropenem will be increased to 2 g three times in day and again, after 24 hours, one hour after end of infusion and half an hour before receiving the next dose of meropenem the blood sample will be drawn. Meropenem concentration will be determined by HPLC method.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Intensive Care Unit,Imam Hossein medical center
Full name of responsible person
Mohammad Sistanizad
Street address
Imam Hossein medical center,Shahid Madani Street, Nezam Abad Neighborhood
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 3437 9032
Email
info@ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd Floor,School of Medicin.Next to Taleghani Hospital,Evin,Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
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
Mohammad Sistanizad
Position
Associated Professor/Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy,Faculty of Pharmacy,Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
sistanizadm@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Associated Professor,Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy,Faculty of Pharmacy,Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
Sistanizadm@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
Department of Clinical Pharmacy,Faculty of Pharmacy,Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
Hassanpour@sbmu.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
Undecided - It is not yet known if there will be 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
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