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

Renal Insufficiency Clinical Trial

— MIRACLE  

Official title:

Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With Estimated Glomerular Filtration Rate LEss Than 30mL/Min/1.73m2

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04598516
• Other study ID #: NL.MUMC.AMACINGrp.1
• Status: Withdrawn
• Start date: November 1, 2097
• Est. completion date: November 1, 2099

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The current prospective observational study proposes to use intra-patient comparisons of peak changes in renal function (serum creatinine) in absence of- and post- intravascular iodinated contrast administration, to elucidate the relationship between renal function and contrast administration in elective patients with eGFR <30 mL/min/1.73m2. The effects of contrast administration on risk of 1-month dialysis and mortality will also be evaluated.

Daily serum creatinine assays will be done 1. during 5 days before contrast (= in absence of contrast), 2. during 5 days after contrast (= post-contrast), and 3. during 5 days at 1-month post contrast (= 1-month post contrast in absence of contrast). Baseline serum creatinine values will be obtained on the day before each 5-day series.

Relevant baseline characteristics of patients will be reported to enable a detailed description of the study population. To explore whether the magnitude of the mean difference in peak change in serum creatinine before and after contrast administration depends on other factors, pre-planned subgroup analyses will be performed. To enable subgroup analyses, data will be collected on 1) prophylactic hydration (yes vs no); 2) administration route (intra-arterial versus intravenous contrast administration); 3) contrast volume (high vs low) and 4) comorbidity (presence vs absence of diabetes).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2099
• Est. primary completion date: November 1, 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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+

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• serum creatinine assay
peak change in serum creatinine in a period of 5 days from baseline (day 0) will be determined

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	mean intra-patient difference between peak changes in serum creatinine occurring within 5 days pre-contrast and 5 days at 1-month post-contrast from baseline measurements (baseline = measurement on the day before every 5-day series). Peak change in eGFR will also be calculated based on the peak serum creatinine values.	5 days
Secondary	Time to post-contrast peak change in serum creatinine.	Time to greatest post-contrast change in serum creatinine from baseline (day 0) within 5 days after contrast administration.	5 days
Secondary	Acute kidney injury in absence of- vs post-contrast.	Incidences of peak changes in serum creatinine corresponding to definitions for classic CIN (an increase in serum creatinine greater than 44umol/l or greater than 25% from baseline) and KDIGO acute kidney injury (an increase in serum creatinine greater than 26.5 umol/L from baseline or more than 1.5 times the baseline value). Peak changes will be determined within 5 days pre-contrast and 5 days post-contrast.	5 days
Secondary	1 month eGFR decline >=5 mL/min/1.73m2.	Incidences of peak eGFR decline >=5 mL/min/1.73m2 within 5 days pre- and within 5 days at 1-month post-contrast	1 month, 1 year
Secondary	1 month dialysis and mortality.	Incidences of dialysis and mortality at 1 month post-contrast.	1 month