Acute Kidney Injury (Nontraumatic)MIRACLENCT04598516
Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30
An observational study of Acute Kidney Injury (Nontraumatic) and Contrast-induced Nephropathy, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic), Contrast-induced Nephropathy, Renal Insufficiency
- What is being tested?
- serum creatinine assay
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2097to 1 Nov 2099
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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+
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Being tested
- serum creatinine assay
- Keywords
- intravascular iodinated contrast, Post-Contrast Acute Kidney Injury, Contrast-induced acute kidney injury
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum creatinine assayDiagnostic test
peak change in serum creatinine in a period of 5 days from baseline (day 0) will be determined
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 5 days
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.
Measured: 5 days
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.
Measured: 5 days
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
Measured: 1 month, 1 year
1 month dialysis and mortality.
Incidences of dialysis and mortality at 1 month post-contrast.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2097 (estimated)
- Primary completion1 Nov 2099 (estimated)
- Study completion1 Nov 2099 (estimated)
Why it stopped: delay
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598516
- Sponsor's protocol ID
- NL.MUMC.AMACINGrp.1
- Acronym
- MIRACLE
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04598516
- Acronym / sponsor ID
- MIRACLE / NL.MUMC.AMACINGrp.1
- Keywords
- intravascular iodinated contrast, Post-Contrast Acute Kidney Injury, Contrast-induced acute kidney injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: delay
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2097 (estimated)
- Primary completion
- 1 Nov 2099 (estimated)
- Study completion
- 1 Nov 2099 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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+
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum creatinine assaypeak change in serum creatinine in a period of 5 days from baseline (day 0) will be determined | Diagnostic test | – |
Primary outcome
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 secondary outcomes
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
Time to post-contrast peak change in serum creatinine.
Time frame: 5 days
Acute kidney injury in absence of- vs post-contrast.
Time frame: 5 days
1 month eGFR decline >=5 mL/min/1.73m2.
Time frame: 1 month, 1 year
1 month dialysis and mortality.
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury (Nontraumatic)
Active, not recruiting
Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery
Acute Kidney Injury (Nontraumatic)
Recruiting
WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity CRRT in Critically Ill Patients
Acute Kidney Injury (Nontraumatic), Dialysis; Complications
RecruitingObservational study
AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
Acute Kidney Injury (Nontraumatic), Hypotension Drug-Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury (Nontraumatic) and Contrast-induced Nephropathy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.