Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30

NCT04598516 | Withdrawn

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

Brief Summary

Intravascular iodinated contrast administration has become crucial to modern medicine. Currently it is estimated that over 250 million injections are given each year worldwide during medical scans and interventions. An acute predefined increase in serum creatinine is considered an indicator of acute kidney injury (AKI). When such an acute increase in serum creatinine occurs within 5 days post-contrast in absence of another aetiology, it is assumed to be iodinated contrast administration induced acute kidney injury. For over 50 years now, acute kidney injury caused by intravascular administration of iodinated contrast material has been considered a leading cause of hospital-acquired renal failure. Contrast has been withheld in fear of kidney injury with misdiagnoses and delayed appropriate patient management as a result. Since 2018, it is now widely accepted that only patients with eGFR \<30 mL/min/1.73m2 are at risk of renal injury after intravascular iodinated contrast material injection. However, no study to date has been able to distinguish acute kidney injury caused by iodinated contrast administration from that for which no causal link is established, and it is unsure a causal relationship exists. There are several studies, in attempts to evaluate the causal relationship between contrast exposure and nephrotoxicity, that found fluctuations in absence of contrast similar to those considered to be contrast-induced acute kidney injury. Similarly, it is unsure whether longer-term negative outcomes are inherent to the population studied or a result of contrast administration. However, most of these studies are observational and retrospective in nature. The issue with retrospective studies is that they often cannot control for confounders and therefore cannot give us causation, only association. On the other hand, prospective randomized controlled trials comparing intravascular iodinated contrast administration to no contrast are unlikely given evident ethical issues. The current prospective observational study proposes to use intra-patient comparisons of peak change in renal function during periods in absence of- and with contrast to elucidate the relationship between renal function and contrast administration in this population.

Conditions

Acute Kidney Injury (Nontraumatic); Contrast-induced Nephropathy; Renal Insufficiency

Keywords

intravascular iodinated contrast; Post-Contrast Acute Kidney Injury; Contrast-induced acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Mean difference in peak change in serum creatinine from baseline between a 5 day period before contrast and a 5 day period immediately after contrast.

  The underlying hypothesis is that intravascular iodinated contrast administration will cause greater peak changes in serum creatinine within 5 days. The primary outcome is peak changes in serum creatinine within 5 days from a baseline measurement. The effect of contrast administration will be expressed as the mean intra-patient difference in peak changes in serum creatinine between pre- and post-contrast periods. Peak change in eGFR will also be calculated based on the peak serum creatinine values.

  5 days

Secondary Outcomes (5)

• Mean difference in peak change in serum creatinine from baseline between a 5 day period before contrast and a 5 day period at 1-month post-contrast.

  5 days

• Time to post-contrast peak change in serum creatinine.

  5 days

• Acute kidney injury in absence of- vs post-contrast.

  5 days

• 1 month eGFR decline >=5 mL/min/1.73m2.

  1 month, 1 year

• 1 month dialysis and mortality.

  1 month

Interventions

serum creatinine assay DIAGNOSTIC_TEST

peak change in serum creatinine in a period of 5 days from baseline (day 0) will be determined

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

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+ are eligible for inclusion.

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+

You may not qualify if:

• age \<18 years
• dialysis or pre-dialysis
• intravascular contrast administration \<30 days before the first baseline measurement
• emergency or intensive care status
• inability to complete follow-up

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples may be stored for renal damage biomarker assays

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

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

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 22, 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)