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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03045692
• Other study ID #: 2016-12-147-003
• Status: Not yet recruiting
• Phase: N/A
• First received: February 5, 2017
• Last updated: February 6, 2017
• Start date: February 13, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: Jung Eun Lee, MD,PhD
• Phone: 82-2-3410-6549
• Email: jungeun34.lee[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Critical Illness
• ICU Patients

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

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)