Time to Excretion of Contrast, a Maastricht Prospective Observational Study

NCT04603261 | Withdrawn

• 1 other identifier: NL.MUMC.AMACINGrp.2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• % contrast elimination.

  5 days

• contrast elimination versus adverse post-contrast outcomes.

  1 month

Study Arms (3)

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

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

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

Interventions

Contrast concentration in urine 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; eGFR <30 mL/min/1.73m2; eGFR >=60 mL/min/1.73m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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+

You may qualify if:

• \- 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:
• \. 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.
• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and urine samples may be stored for renal injury biomarker assays

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury

Interventions

Urination

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 26, 2020
• Study Start (Estimated): November 1, 2097
• Primary Completion (Estimated): November 1, 2099
• Study Completion (Estimated): November 1, 2099
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)