Time to Excretion of Contrast, a Maastricht Prospective Observational Study

NCT ID: NCT04603261

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2097-11-01
• Study Completion Date: 2099-11-01

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).

Conditions

Renal Insufficiency; Acute Kidney Injury; Contrast-induced Nephropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

eGFR <30 mL/min/1.73m2

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+.

Contrast concentration in urine

Intervention Type: DIAGNOSTIC_TEST

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.

eGFR 30-59 mL/min/1.73m2

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.

Contrast concentration in urine

Intervention Type: DIAGNOSTIC_TEST

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.

eGFR >=60 mL/min/1.73m2

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.

Contrast concentration in urine

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht UMC

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

NL.MUMC.AMACINGrp.2

Identifier Type: -

Identifier Source: org_study_id