Establishment of a Creatinine Clearance Estimation Equation and Daily Creatinine Excretion Reference Table for Taiwanese

It's important to dose according to renal function in who has impaired kidney function. There are two common methods estimating renal function: one is creatinine clearance estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD) equation.

The previous study (not published) showed that CG underestimated 24 hour measured urine creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to establish a estimated creatinine clearance equation fitting in Taiwanese.

Besides, there are lots of studies discussing difference between CG and MDRD. We have found that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis which characteristics of patients the difference are largest or smallest.

Study Overview

• Status: Completed
• Conditions: Estimated Creatinine Clearance

• Study Type: Observational
• Enrollment (Actual): 700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients or inpatients of National Taiwan University Hospital who had 24 hour urine creatinine collections during 2010/1/1 to 2012/12/31.

Description

Inclusion Criteria:

• age above or equal to 20 year-old adults
• had 24 hour urine creatinine collection

Exclusion Criteria:

• lack of at least one :sex, diagnosis, age,weight, height
• serum creatinine beyond linear test range
• with extreme weight or height
• with acute kidney injury or specific diagnosis
• with extremities of daily urine creatinine excretion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coefficient of determination of estimated creatinine clearance equation	Compare new estimated creatinine clearance equation for Taiwanese with Cockcroft-Gault equation	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences of daily urine creatinine excretion between Caucasian and Taiwanese	3 years

Other Outcome Measures

Outcome Measure	Time Frame
In which subgroup that difference between CG and MDRD is smallest or largest	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Fe-Lin Lin, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 22, 2013
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: renal function, creatinine clearance
• Other Study ID Numbers: 201311047RINC