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

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Insufficiency; Acute Kidney Injury; Contrast-induced Nephropathy
• Intervention / Treatment: Diagnostic test: Contrast concentration in urine

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).

• Study Type: Observational

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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+

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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+.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to contrast-free urine.	time to the first contrast-free urine sample from the time of intravascular iodinated contrast administration. Time to contrast-free urine will be compared between three groups of patients (with eGFR <30 mL/min/1.73m2, eGFR 30-59 mL/min/1.73m2, and eGFR >=60 mL/min/1.73m2).	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% contrast elimination.	percentage of total contrast administered excreted in urine within 5 days. Percentage contrast elimination will be compared between three groups of patients (with eGFR <30 mL/min/1.73m2, eGFR 30-59 mL/min/1.73m2, and eGFR >=60 mL/min/1.73m2).	5 days
contrast elimination versus adverse post-contrast outcomes.	The underlying hypothesis is that delayed elimination increases contrast toxicity which increases adverse event risk. This will be explored by comparing percentages with post-contrast adverse events (acute kidney injury; changes in eGFR; eGFR decline ≥5mL/min/1.73m2; dialysis; mortality; up to 1-month) in groups with and without delayed elimination, stratified by eGFR (<30, 30-59, ≥60). Relevant patient and procedural characteristics will also be compared to identify potential predictors of delayed elimination. Contrast elimination times are unknown, therefore 'delayed' is defined as time to contrast-free urine exceeding patient group median value. In clinical practice, normal contrast elimination is assumed to be ≥24h. Therefore, 1. Normal (≤24h); 2. Delayed (24-48h); 3. Severely delayed (>48h) elimination subgroups will also be compared. Subgroup cut-off values may be added at a later stage (e.g., in the event of many or no patients with elimination >48h).	1 month

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2097
• Primary Completion (Estimated): November 1, 2099
• Study Completion (Estimated): November 1, 2099

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: contrast-induced acute kidney injury; intravascular iodinated contrast; post-contrast acute kidney injury; iodinated contrast elimination time; contrast retention; delayed contrast elimination
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: NL.MUMC.AMACINGrp.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No