Clinical trial NCT04603261: Time to Excretion of Contrast, a Maastricht Prospective Observational Study
Official title: Time to Excretion of Contrast, a Maastricht Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Insufficiency
Acute Kidney Injury
Contrast-induced Nephropathy
Keywords: intravascular iodinated contrast
contrast-induced acute kidney injury
post-contrast acute kidney injury
iodinated contrast elimination time
contrast retention
delayed contrast elimination
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive eligible patients with eGFR \<30 mL/min/1.73m2 and matched eGFR 30-59 mL/min/1.73m2 and eGFR \>=60 mL/min/1.73m2 patients referred for an elective procedure with intravascular iodinated contrast at Maastricht UMC+

Brief 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).

Eligibility criteria: Inclusion Criteria:

- eGFR \<30 mL/min/1.73m2 in absence of dialysis referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+

For each included patient with eGFR \<30 mL/min/1.73m2, two matched patients will be included:

* 1. eGFR 30-59 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR \<30 mL/min/1.73m2 participant.
* 2. eGFR \>=60 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR \<30 mL/min/1.73m2 participant.

Exclusion Criteria:

* age \<18 years
* dialysis or pre-dialysis
* intravascular contrast administration having occurred \<30 days before the first baseline sample
* emergency or intensive care status.

Primary outcomes:
measure: time to contrast-free urine.
timeFrame: 5 days
Secondary outcomes:
measure: % contrast elimination.
timeFrame: 5 days
measure: contrast elimination versus adverse post-contrast outcomes.
timeFrame: 1 month
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
References: