Renal InsufficiencyTEMPOSNCT04603261
Time to Excretion of Contrast, a Maastricht Prospective Observational Study
An observational study of Renal Insufficiency and Acute Kidney Injury, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Acute Kidney Injury, Contrast-induced Nephropathy
- What is being tested?
- Contrast concentration in urine
- 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: consecutive eligible patients with eGFR <30 mL/min/1.73m2 and matched eGFR 30-59 mL/min/1.73m2 and eGFR >=60 mL/min/1.73m2 patients referred for an elective procedure with intravascular iodinated contrast at Maastricht UMC+
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+
- For each included patient with eGFR <30 mL/min/1.73m2, two matched patients will be included:
- 1. eGFR 30-59 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR <30 mL/min/1.73m2 participant.
- 2. eGFR >=60 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR <30 mL/min/1.73m2 participant.
Who cannot join
- age <18 years
- dialysis or pre-dialysis
- intravascular contrast administration having occurred <30 days before the first baseline sample
- emergency or intensive care status.
Trial locations and contacts
1 site in 1 country.
About this study
Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.
Read the detailed description
The primary aim of the current study is to determine contrast elimination time and % in three groups of patients, (with severely reduced, moderate, and mildly reduced to normal renal function). Secondary aims are to explore whether specific situations/characteristics result in higher probability of delayed elimination of contrast, and whether there is a link between elimination time and adverse post-contrast outcomes (post-contrast incidences of acute kidney injury; post-contrast changes in eGFR within 5 days from baseline; 1-month post-contrast change in eGFR; 1-month post-contrast incidences of eGFR decline >=5 mL/min/1.73m2; 1-month dialysis and mortality).
- Being tested
- Contrast concentration in urine
- Keywords
- intravascular iodinated contrast, contrast-induced acute kidney injury, post-contrast acute kidney injury, iodinated contrast elimination time, contrast retention, delayed contrast elimination
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast concentration in urineDiagnostic test
Iodinated contrast content of urine samples, collected post-contrast over a period of 5 days at all times of natural excretion within that period, will be assayed.
Serum creatinine will be measured daily before (day 0) and during 5 days post-contrast, and again at 1 month post-contrast.
| Study group | Role | What they receive |
|---|---|---|
| eGFR <30 mL/min/1.73m2 | 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+. Receives: Diagnostic Test: Contrast concentration in urine | |
| eGFR 30-59 mL/min/1.73m2 | For each included patient with eGFR <30 mL/min/1.73m2, two patients matched for age, sex and contrast procedure type will be included: one with eGFR 30-59 mL/min/1.73m2 and one with eGFR >=60 mL/min/1.73m2. Receives: Diagnostic Test: Contrast concentration in urine | |
| eGFR >=60 mL/min/1.73m2 | For each included patient with eGFR <30 mL/min/1.73m2, two patients matched for age, sex and contrast procedure type will be included: one with eGFR 30-59 mL/min/1.73m2 and one with eGFR >=60 mL/min/1.73m2. Receives: Diagnostic Test: Contrast concentration in urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to contrast-free urine.
time to the first contrast-free urine sample from the time of intravascular iodinated contrast administration. Time to contrast-free urine will be compared between three groups of patients (with eGFR <30 mL/min/1.73m2, eGFR 30-59 mL/min/1.73m2, and eGFR >=60 mL/min/1.73m2).
Measured: 5 days
Secondary outcomes (2)
% contrast elimination.
percentage of total contrast administered excreted in urine within 5 days. Percentage contrast elimination will be compared between three groups of patients (with eGFR <30 mL/min/1.73m2, eGFR 30-59 mL/min/1.73m2, and eGFR >=60 mL/min/1.73m2).
Measured: 5 days
contrast elimination versus adverse post-contrast outcomes.
The underlying hypothesis is that delayed elimination increases contrast toxicity which increases adverse event risk. This will be explored by comparing percentages with post-contrast adverse events (acute kidney injury; changes in eGFR; eGFR decline ≥5mL/min/1.73m2; dialysis; mortality; up to 1-month) in groups with and without delayed elimination, stratified by eGFR (<30, 30-59, ≥60). Relevant patient and procedural characteristics will also be compared to identify potential predictors of delayed elimination.
Contrast elimination times are unknown, therefore 'delayed' is defined as time to contrast-free urine exceeding patient group median value. In clinical practice, normal contrast elimination is assumed to be ≥24h. Therefore, 1. Normal (≤24h); 2. Delayed (24-48h); 3. Severely delayed (>48h) elimination subgroups will also be compared. Subgroup cut-off values may be added at a later stage (e.g., in the event of many or no patients with elimination >48h).
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 posted26 Oct 2020
- Study start1 Nov 2097 (estimated)
- Primary completion1 Nov 2099 (estimated)
- Study completion1 Nov 2099 (estimated)
Why it stopped: delayed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- NCT04603261
- Sponsor's protocol ID
- NL.MUMC.AMACINGrp.2
- Acronym
- TEMPOS
- 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
- Time to Excretion of Contrast, a Maastricht Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04603261
- Acronym / sponsor ID
- TEMPOS / NL.MUMC.AMACINGrp.2
- Keywords
- intravascular iodinated contrast, contrast-induced acute kidney injury, post-contrast acute kidney injury, iodinated contrast elimination time, contrast retention, delayed contrast elimination
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: delayed
- 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
- 26 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.
Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.
Detailed description
The primary aim of the current study is to determine contrast elimination time and % in three groups of patients, (with severely reduced, moderate, and mildly reduced to normal renal function). Secondary aims are to explore whether specific situations/characteristics result in higher probability of delayed elimination of contrast, and whether there is a link between elimination time and adverse post-contrast outcomes (post-contrast incidences of acute kidney injury; post-contrast changes in eGFR within 5 days from baseline; 1-month post-contrast change in eGFR; 1-month post-contrast incidences of eGFR decline >=5 mL/min/1.73m2; 1-month dialysis and mortality).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eGFR <30 mL/min/1.73m2 | – | Diagnostic Test: Contrast concentration in urinePatients 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+. |
| eGFR 30-59 mL/min/1.73m2 | – | Diagnostic Test: Contrast concentration in urineFor each included patient with eGFR <30 mL/min/1.73m2, two patients matched for age, sex and contrast procedure type will be included: one with eGFR 30-59 mL/min/1.73m2 and one with eGFR >=60 mL/min/1.73m2. |
| eGFR >=60 mL/min/1.73m2 | – | Diagnostic Test: Contrast concentration in urineFor each included patient with eGFR <30 mL/min/1.73m2, two patients matched for age, sex and contrast procedure type will be included: one with eGFR 30-59 mL/min/1.73m2 and one with eGFR >=60 mL/min/1.73m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive eligible patients with eGFR <30 mL/min/1.73m2 and matched eGFR 30-59 mL/min/1.73m2 and eGFR >=60 mL/min/1.73m2 patients referred for an elective procedure with intravascular iodinated contrast at Maastricht UMC+
Key inclusion criteria (4 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+
- For each included patient with eGFR <30 mL/min/1.73m2, two matched patients will be included:
- 1. eGFR 30-59 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR <30 mL/min/1.73m2 participant.
- 2. eGFR >=60 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR <30 mL/min/1.73m2 participant.
Key exclusion criteria (4 listed)
- age <18 years
- dialysis or pre-dialysis
- intravascular contrast administration having occurred <30 days before the first baseline sample
- emergency or intensive care status.
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 |
|---|---|---|
| Contrast concentration in urineIodinated contrast content of urine samples, collected post-contrast over a period of 5 days at all times of natural excretion within that period, will be assayed. Serum creatinine will be measured daily before (day 0) and during 5 days post-contrast, and again at 1 month post-contrast. | Diagnostic test | eGFR 30-59 mL/min/1.73m2, eGFR <30 mL/min/1.73m2, eGFR >=60 mL/min/1.73m2 |
Primary outcome
time to contrast-free urine.
Time frame: 5 days
time to the first contrast-free urine sample from the time of intravascular iodinated contrast administration. Time to contrast-free urine will be compared between three groups of patients (with eGFR <30 mL/min/1.73m2, eGFR 30-59 mL/min/1.73m2, and eGFR >=60 mL/min/1.73m2).
2 secondary outcomes
% contrast elimination.
Time frame: 5 days
contrast elimination versus adverse post-contrast outcomes.
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
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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 Renal Insufficiency and Acute Kidney Injury, 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 4 inclusion and 4 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?
time to contrast-free urine. (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.