NCT04603261

Time to Excretion of Contrast, a Maastricht Prospective Observational Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR \<30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR \<30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR \>=60 mL/min/1.73m2.

Detailed description

The primary aim of the current study is to determine contrast elimination time and % in three groups of patients, (with severely reduced, moderate, and mildly reduced to normal renal function). Secondary aims are to explore whether specific situations/characteristics result in higher probability of delayed elimination of contrast, and whether there is a link between elimination time and adverse post-contrast outcomes (post-contrast incidences of acute kidney injury; post-contrast changes in eGFR within 5 days from baseline; 1-month post-contrast change in eGFR; 1-month post-contrast incidences of eGFR decline \>=5 mL/min/1.73m2; 1-month dialysis and mortality).

Conditions

• Renal Insufficiency
• Acute Kidney Injury
• Contrast-induced Nephropathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast concentration in urine	Iodinated contrast content of urine samples, collected post-contrast over a period of 5 days at all times of natural excretion within that period, will be assayed. Serum creatinine will be measured daily before (day 0) and during 5 days post-contrast, and again at 1 month post-contrast.

Timeline

• Start date: 2097-11-01
• Primary completion: 2099-11-01
• Completion: 2099-11-01
• First posted: 2020-10-26
• Last updated: 2023-10-19

Locations

1 site across 1 country: Netherlands