Are point-of-care albumin/creatinine measurements accurate in critically ill patients?

Completed

• Conditions: Critically Ill; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12618000341224
• Lead Sponsor: uke Weinel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-06
• Study Completion: 2018-05-25
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•>18 years of age
•Arterial line in situ
•Catheter in situ

Exclusion Criteria

Exclusion criteria are conditions which affect albumin/creatinine results including patients with anuria or haematuria; pre-existing chronic kidney disease (as defined by an abnormal creatinine on previous testing if available); pre-existing diabetes mellitus; known proteinuria due to renal or post-renal causes and urinary tract infection.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is measurement of agreement between the POC analyser and laboratory analysis of albumin/creatinine measurements,<br><br>Agreement between measures will be analysed by Lin’s concordance correlation coefficient with Bland-Altman plots including 95% confidence limits of agreement. References 1 and 2.<br><br>1.Lin, L. I-K. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45: 255-268.<br>2.Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet I: 307-310.[The timepoint of the primary outcome is the time at which a urine sample is taken for albumin/creatinine analysis.]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is a composite outcome to determine feasibility of using the POC analyser for routine use in the ICU setting. This will be determined by time efficiency and frequency of errors. Time efficiency will be calculated by reporting the time from urine sample acquisition to the POC result read out and by reporting the time from sending the urine sample to the central laboratory to time of reporting. The frequency of errors will be determined by the occurrence of errors resulting in no result readout. These errors are displayed as specific codes referring to a potential cause on the analyser screen.[At time of albumin/creatinine analysis following patient admission to ICU.]