Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients
Primary Purpose
ICU Patients
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kidney function assessment by 4 hour creatinine clearance
kidney function assessment by creatinine based eGFR
Sponsored by
About this trial
This is an interventional treatment trial for ICU Patients focused on measuring drug dosing, eGFR, CCr
Eligibility Criteria
Inclusion Criteria:
- Patients aged over 18
- Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.
Exclusion Criteria:
- Patients who received colistin empirically.
- Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
- Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
- Patients who underwent hematopoietic stem cell transplantation
- Patients who disagree with this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Study group
Arm Description
creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.
4 hour creatinine clearance is used to decide colistin maintenance dosage.
Outcomes
Primary Outcome Measures
composite outcome (combination of nephrotoxicity or treatment failure)
Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'
Secondary Outcome Measures
colistin trough level, renal clearance of colistin
ICU stay duration
Total duration of colistin treatment
Need for renal replacement therapy
In-ICU mortality (infection-attributed mortality)
Full Information
NCT ID
NCT03045692
First Posted
February 5, 2017
Last Updated
February 6, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03045692
Brief Title
Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients
Official Title
Reliable Methods to Assess Kidney Function for Drug Dosage Adjustments in Critically Ill Patients - Comparison of Timed Clearance of Creatinine and Creatinine Based Estimated GFR
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2017 (Anticipated)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be decided using 4hr CrCl.
Detailed Description
Screening periods (From 'informed consents' to 'randomization')
Check of inclusion/exclusion criteria ② Measurement of 4hr CrCl & eGFR in ml/min
calculation of maintenance dose ③ Baseline characteristics & laboratory findings ④ Randomization
Colistin dosage Loading dose : 5 x body weight (not exceeding 300mg) Maintenance dose (after 12 hours from loading dose)
: 2.5 x ([1.5 x GFR] + 30) (divided doses every 12hours), GFR in ml/min
During the study period, daily morning serm creatinine levels are measured. Whenever serum creatinine concentration changes by more than 10% compared with baseline, 4hr CrCl will be mearued. At the every time of 4hr CrCl measurements, colistin dose wil be modified according to new GFR values (4hr CrCl in study group, eGFR in control group)
Blood sampling for Colistin trough level measurement Peripheral blood will be sampled twice between 72 hrs and 144 hours after loading dose, just before colistin infusion. The samples were collected in heparined tubes and centrifuged at 4 °C within 1 hr of collection. The resulting plasma was stored at - 70°C . And two values will be averaged out.
End of randomization (7 days after colistin initiation) ① Nephrotoxicity ② Treatment outcome microbiological outcome: eradication / no eradication clinical outcome: complete response / partial response / treatment failure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Patients
Keywords
drug dosing, eGFR, CCr
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.
Arm Title
Study group
Arm Type
Experimental
Arm Description
4 hour creatinine clearance is used to decide colistin maintenance dosage.
Intervention Type
Diagnostic Test
Intervention Name(s)
kidney function assessment by 4 hour creatinine clearance
Intervention Description
4 hour creatinine clearance is used to decide colistin maintenance dosage.
Intervention Type
Diagnostic Test
Intervention Name(s)
kidney function assessment by creatinine based eGFR
Intervention Description
creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.
Primary Outcome Measure Information:
Title
composite outcome (combination of nephrotoxicity or treatment failure)
Description
Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'
Time Frame
7 days after colistin initiation
Secondary Outcome Measure Information:
Title
colistin trough level, renal clearance of colistin
Time Frame
7 days after colistin initiation
Title
ICU stay duration
Time Frame
till discharge (Max. 3 months)
Title
Total duration of colistin treatment
Time Frame
till discharge (Max. 3 months)
Title
Need for renal replacement therapy
Time Frame
7 days after colistin initiation
Title
In-ICU mortality (infection-attributed mortality)
Time Frame
till discharge (Max. 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged over 18
Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.
Exclusion Criteria:
Patients who received colistin empirically.
Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
Patients who underwent hematopoietic stem cell transplantation
Patients who disagree with this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Eun Lee, MD,PhD
Phone
82-2-3410-6549
Email
jungeun34.lee@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients
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