Time to Excretion of Contrast, a Maastricht Prospective Observational Study (TEMPOS)

Maastricht University Medical Centre (MUMC)

Status: Withdrawn

Conditions: Acute Kidney Injury; Renal Insufficiency; Contrast-induced Nephropathy

Treatments: Diagnostic Test: Contrast concentration in urine

Study type: Observational

Funder types: Other

Identifiers

NCT04603261

NL.MUMC.AMACINGrp.2

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups

eGFR <30 mL/min/1.73m2

Description:

Patients with 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+.

Treatment:

Diagnostic Test: Contrast concentration in urine

eGFR 30-59 mL/min/1.73m2

Description:

For each included patient with eGFR \<30 mL/min/1.73m2, two patients matched for age, sex and contrast procedure type will be included: one with eGFR 30-59 mL/min/1.73m2 and one with eGFR \>=60 mL/min/1.73m2.

Treatment:

Diagnostic Test: Contrast concentration in urine

eGFR >=60 mL/min/1.73m2

Description:

For each included patient with eGFR \<30 mL/min/1.73m2, two patients matched for age, sex and contrast procedure type will be included: one with eGFR 30-59 mL/min/1.73m2 and one with eGFR \>=60 mL/min/1.73m2.

Treatment:

Diagnostic Test: Contrast concentration in urine