- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04598516
Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 (MIRACLE)
Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With Estimated Glomerular Filtration Rate LEss Than 30mL/Min/1.73m2
Study Overview
Status
Intervention / Treatment
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 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).
Study Type
Contacts and Locations
Study Locations
-
-
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Maastricht, Netherlands
- Maastricht UMC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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+
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 5 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 5 days
|
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
|
Time to post-contrast peak change in serum creatinine.
Time Frame: 5 days
|
Time to greatest post-contrast change in serum creatinine from baseline (day 0) within 5 days after contrast administration.
|
5 days
|
Acute kidney injury in absence of- vs post-contrast.
Time Frame: 5 days
|
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
|
1 month eGFR decline >=5 mL/min/1.73m2.
Time Frame: 1 month, 1 year
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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
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1 month dialysis and mortality.
Time Frame: 1 month
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Incidences of dialysis and mortality at 1 month post-contrast.
|
1 month
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL.MUMC.AMACINGrp.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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