NCT03045692

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• ICU Patients

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	kidney function assessment by 4 hour creatinine clearance	4 hour creatinine clearance is 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.

Timeline

• Start date: 2017-02-13
• Primary completion: 2019-02-28
• Completion: 2019-04-30
• First posted: 2017-02-07
• Last updated: 2017-02-08