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

Not Applicable

Interventions: Diagnostic Test: kidney function assessment by creatinine based eGFR
Diagnostic Test: kidney function assessment by 4 hour creatinine clearance

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: 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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control group	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.
Study group	kidney function assessment by 4 hour creatinine clearance	4 hour creatinine clearance is used to decide colistin maintenance dosage.

Primary Outcome Measures

Name	Time	Method
composite outcome (combination of nephrotoxicity or treatment failure)	7 days after colistin initiation	Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'

Secondary Outcome Measures

Name	Time	Method
In-ICU mortality (infection-attributed mortality)	till discharge (Max. 3 months)
colistin trough level, renal clearance of colistin	7 days after colistin initiation
ICU stay duration	till discharge (Max. 3 months)
Need for renal replacement therapy	7 days after colistin initiation
Total duration of colistin treatment	till discharge (Max. 3 months)

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