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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
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICU Patients focused on measuring drug dosing, eGFR, CCr

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged over 18
  2. Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.

Exclusion Criteria:

  1. Patients who received colistin empirically.
  2. Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
  3. Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
  4. Patients who underwent hematopoietic stem cell transplantation
  5. 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

    First Posted
    February 5, 2017
    Last Updated
    February 6, 2017
    Sponsor
    Samsung Medical Center
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    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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