ICU Patients Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 172 |
Est. completion date | April 30, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite outcome (combination of nephrotoxicity or treatment failure) | Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response' | 7 days after colistin initiation | |
Secondary | colistin trough level, renal clearance of colistin | 7 days after colistin initiation | ||
Secondary | ICU stay duration | till discharge (Max. 3 months) | ||
Secondary | Total duration of colistin treatment | till discharge (Max. 3 months) | ||
Secondary | Need for renal replacement therapy | 7 days after colistin initiation | ||
Secondary | In-ICU mortality (infection-attributed mortality) | till discharge (Max. 3 months) |
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