Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast (EPIC)

Efficacy of Point-of-care Creatinine Assays in Patients With eGFR <30ml/Min/1.73m2 in the Setting of Elective Procedures With Intravascular Iodinated Contrast

Point-of-care (POC) creatinine devices allow rapid measurement of creatinine levels and calculation of estimated glomerular filtration rate (eGFR) which give an indication of renal function. The focus of this assessment is to validate POC measurements to assess kidney function before intravascular iodinated contrast administration in patients with severe renal insufficiency (eGFR < 30 ml/min/1.73m2). It will be evaluated whether discrepancies between POC measurement values and values obtained from standard laboratory assays lie within an acceptable range using Bland-Altman analysis.

Study Overview

• Status: Withdrawn
• Conditions: Renal Insufficiency; Acute Kidney Injury; Contrast-induced Nephropathy
• Intervention / Treatment: Diagnostic test: serum creatinine assay

Detailed Description

Measurement of creatinine to determine eGFR before intravascular iodinated contrast administration is indicated to assess whether a patient is at risk of contrast-induced acute kidney injury (AKI). For patients with reduced eGFR intravenous hydration can be offered before the scan to reduce the risk of AKI. If no recent eGFR measurement is available, contrast procedures could be cancelled and rescheduled while a creatinine test is processed in the laboratory. Using POC creatinine tests before contrast-enhanced procedures could minimise the risk of kidney injury, and may reduce the number of cancelled scans. The question is whether POC creatinine assay is accurate and beneficial in this setting compared to the standard laboratory assay.

The i-STAT Alinity POC creatinine device is one of three devices which calculate estimated glomerular filtration rate (eGFR) recommended in clinical practice guidelines to assess kidney function to guide decisions on the use of intravascular iodinated contrast in adults. In the study, i-STAT Alinity POC measurements of creatinine will be performed using already available blood samples of patients with estimated eGFR<30 ml/min/1.73m2 and mean difference between eGFR and serum creatinine measurements using POC and standard laboratory assays will be calculated. Results will be used to evaluate the agreement between of POC and laboratory assays on risk stratification (i.e., the percentage of patients with eGFR<30 according to both laboratory and POC assays) and post-contrast acute kidney injury (AKI; i.e., the percentage of patients with post-contrast acute kidney injury according to both laboratory and POC assays). Finally, the number of elective procedures which are delayed (including delayed planning) or cancelled because a serum creatinine assay is required and unavailable will be prospectively evaluated for Maastricht UMC+ in this study.

• Study Type: Observational

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Standard care venous blood samples for which eGFR measurement at Maastricht UMC+ Central Diagnostic Laboratory have resulted in a value below 30 ml/min/1.73m2 (including all standard care venous blood samples from patients with GFR <30 ml/min/1.73m2 referred for an elective procedure with intravascular iodinated contrast at Maastricht UMC+) will be used in this study.

Description

Inclusion Criteria:

• Standard care venous blood samples for which eGFR measurement at Maastricht UMC+ Central Diagnostic Laboratory results in a value below 30 ml/min/1.73m2 (including all standard care venous blood samples from patients with GFR <30 ml/min/1.73m2 referred for an elective procedure with intravascular iodinated contrast at Maastricht UMC+)

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference between eGFR and serum creatinine measurements using POC and standard laboratory assays	with 95% limits of agreement (based on the standard deviation of the individual between-method differences).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement risk stratification.	percentage of patients classified as eGFR <30 by both POC and standard laboratory assays	6 months
Agreement post-contrast acute kidney injury.	percentage of patients with post-contrast AKI according to both POC and standard laboratory assays	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed/cancelled procedures.	The percentage of elective procedures which are delayed (including delayed planning) or cancelled because a serum creatinine assay is required and unavailable will be prospectively evaluated for Maastricht UMC+ in this study.	6 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2097
• Primary Completion (Estimated): March 1, 2099
• Study Completion (Estimated): March 1, 2099

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: NL.MUMC.AMACINGrp.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No