ICU Patients
Conditions
Keywords
drug dosing, eGFR, CCr
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
Interventions
DIAGNOSTIC_TESTkidney function assessment by 4 hour creatinine clearance
4 hour creatinine clearance is used to decide colistin maintenance dosage.
DIAGNOSTIC_TESTkidney 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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Double blind randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| colistin trough level, renal clearance of colistin | 7 days after colistin initiation |
| ICU stay duration | till discharge (Max. 3 months) |
| Total duration of colistin treatment | till discharge (Max. 3 months) |
| Need for renal replacement therapy | 7 days after colistin initiation |
| In-ICU mortality (infection-attributed mortality) | till discharge (Max. 3 months) |
Contacts
Primary ContactJung Eun Lee, MD,PhD
Outcome results
None listed