Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598516
Status:
WITHDRAWN
Last Update Posted:
2023-10-19
First Post:
2020-10-07
Brief Title:
Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With Estimated Glomerular Filtration Rate LEss Than 30mLMin173m2
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
delay
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRACLE
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 mLmin173m2 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
Detailed 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 mLmin173m2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None