Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients
NCT ID: NCT03045692
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
172 participants
INTERVENTIONAL
2017-02-13
2019-04-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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
4 hour creatinine clearance is used to decide colistin maintenance dosage.
kidney function assessment by 4 hour creatinine clearance
4 hour creatinine clearance is used to decide colistin maintenance dosage.
Interventions
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kidney function assessment by 4 hour creatinine clearance
4 hour creatinine clearance is used to decide colistin maintenance dosage.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Jung Eun Lee
Associate professor
Central Contacts
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Other Identifiers
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2016-12-147-003
Identifier Type: -
Identifier Source: org_study_id
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