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Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045692
Recruitment Status : Unknown
Verified February 2017 by Jung Eun Lee, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Jung Eun Lee, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
ICU Patients Diagnostic Test: kidney function assessment by 4 hour creatinine clearance Diagnostic Test: kidney function assessment by creatinine based eGFR Not Applicable

Detailed Description:
  1. 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
  2. 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)

  3. 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.
  4. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 13, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine

Arm Intervention/treatment
Active Comparator: Control group
creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.
Diagnostic Test: kidney function assessment by creatinine based eGFR
creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.

Experimental: Study group
4 hour creatinine clearance is used to decide colistin maintenance dosage.
Diagnostic Test: kidney function assessment by 4 hour creatinine clearance
4 hour creatinine clearance is used to decide colistin maintenance dosage.




Primary Outcome Measures :
  1. composite outcome (combination of nephrotoxicity or treatment failure) [ Time Frame: 7 days after colistin initiation ]
    Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'


Secondary Outcome Measures :
  1. colistin trough level, renal clearance of colistin [ Time Frame: 7 days after colistin initiation ]
  2. ICU stay duration [ Time Frame: till discharge (Max. 3 months) ]
  3. Total duration of colistin treatment [ Time Frame: till discharge (Max. 3 months) ]
  4. Need for renal replacement therapy [ Time Frame: 7 days after colistin initiation ]
  5. In-ICU mortality (infection-attributed mortality) [ Time Frame: till discharge (Max. 3 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045692


Contacts
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Contact: Jung Eun Lee, MD,PhD 82-2-3410-6549 jungeun34.lee@samsung.com

Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Jung Eun Lee, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03045692    
Other Study ID Numbers: 2016-12-147-003
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jung Eun Lee, Samsung Medical Center:
drug dosing, eGFR, CCr
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Colistin
Anti-Bacterial Agents
Anti-Infective Agents