Study Stopped
delay
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
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2097
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
May 1, 2097
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2099
Study Completion
Last participant's last visit for all outcomes
March 1, 2099
October 19, 2023
October 1, 2023
1.8 years
October 7, 2020
October 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Agreement risk stratification.
6 months
Agreement post-contrast acute kidney injury.
6 months
Other Outcomes (1)
Delayed/cancelled procedures.
6 months
Interventions
point-of-care and standard laboratory assay of serum creatinine
Eligibility Criteria
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.
You may qualify if:
- 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+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht UMC
Maastricht, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 22, 2020
Study Start (Estimated)
May 1, 2097
Primary Completion (Estimated)
March 1, 2099
Study Completion (Estimated)
March 1, 2099
Last Updated
October 19, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share